The Medical Device Industry: Market Opportunities in Latin America
Zore Mora Hernández
Lesly Castro2015
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A analysis and evaluation of the market opportunities in Latin America for a German family enterprise involved in the global medical device trade industry. Research project developed with a co-author during graduate studies.
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The Medical Device Industry:
Market Opportunities in Latin
America
Latin America Market Research………………………………………….
1
CONTENTS
INTRODUCTION .............................................................................................................................4
Background ......................................................................................................................................5
COUNTRY EVALUATION ..............................................................................................................7
Description of the research ..............................................................................................................7
Methodology ....................................................................................................................................7
MEDICAL DEVICE MARKET .....................................................................................................10
Latin America ................................................................................................................................10
CHILE ..............................................................................................................................................15
General Country Information.........................................................................................................15
Country Economic Indicators ........................................................................................................15
Political Environment ....................................................................................................................16
Social and Cultural Environment ...................................................................................................17
General Business Environment ......................................................................................................18
Market Value ..................................................................................................................................19
Market Size – Hospitals .................................................................................................................19
Nature of Demand for the Company’s Products ............................................................................20
Regulatory Environment ................................................................................................................20
Market Entry ..................................................................................................................................22
Potential Distributors .....................................................................................................................22
General Information for Importers...................................................................................................7
Competitors......................................................................................................................................7
Market Risks ....................................................................................................................................8
Further recommendations ................................................................................................................8
COLOMBIA.......................................................................................................................................6
General Country Information...........................................................................................................6
General Country Economic Indicators.............................................................................................6
Political Environment ......................................................................................................................8
Social and Cultural Environment .....................................................................................................9
General Business Environment ......................................................................................................10
Market Value .................................................................................................................................. 11
Market Size- Hospitals...................................................................................................................12
Nature of Demand for the Company’s Products ............................................................................13
Regulatory Environment ................................................................................................................13
Market Entry ....................................................................................................................................7
Potential Distributors .......................................................................................................................8
Latin America Market Research………………………………………….
2
General Information for Importers...................................................................................................8
Competitors......................................................................................................................................9
Market Risks ....................................................................................................................................9
Further Information........................................................................................................................41
MEXICO ..........................................................................................................................................47
General Country Information.........................................................................................................47
General Country Economic Indicators...........................................................................................47
Political Environment ....................................................................................................................48
Social and Cultural Environment ...................................................................................................49
General Business Environment ......................................................................................................51
Market Value ..................................................................................................................................52
Market Size – Hospitals ...................................................................................................................7
Nature of Demand for the Company’s Products ..............................................................................7
Regulatory Environment ................................................................................................................57
Market Entry ..................................................................................................................................59
Potential Distributors .....................................................................................................................60
General Information for Importers.................................................................................................60
Competitors....................................................................................................................................61
Market Risks ..................................................................................................................................62
Further Recommendations .............................................................................................................63
CONCLUSION ................................................................................................................................64
CONTACT INFORMATION .........................................................................................................65
INSTITUTION INFORMATION ..................................................................................................65
ABBREVIATIONS ..........................................................................................................................66
REFERENCES ................................................................................................................................67
ANNEXES ........................................................................................................................................71
Annex 1. Map of America..............................................................................................................71
Annex 2. List of Countries per region ...........................................................................................72
Annex 3. Variables and Weights ....................................................................................................65
Annex 4. Indicators from Doing Business Report .........................................................................65
Annex 5. Indicators from World Bank ...........................................................................................66
Annex 6. Industry Indicators..........................................................................................................66
Annex 7. Final Ranking .................................................................................................................67
Annex 8. Map of Chile...................................................................................................................67
Annex 9. Map of Colombia ...........................................................................................................68
Annex 10. Map of Mexico .............................................................................................................68
Latin America Market Research………………………………………….
3
List of Tables
Table 1 . Market Research Indicators and Description ............................................................................... 8
Table 2 . Hospital Beds vs. Population ..................................................................................................... 11
Table 3 . Market Size Summary................................................................................................................ 12
Table 4 . Chile´s Economic Indicators ...................................................................................................... 16
Table 5 . Market Size- Hospitals............................................................................................................... 20
Table 6 . Classification of Medical Devices ............................................................................................. 21
Table 7 . Economic Indicators of Colombia ............................................................................................... 8
Table 8 . Market Size- Hospitals............................................................................................................... 13
Table 9: Mexico’s Economic Indicators ................................................................................................... 48
Table 10: Market Size – Hospitals .............................................................................................................. 7
List of Figures
Figure 1 . Medical Device Imports by Country ........................................................................................ 11
Figure 2 . Medical Device CAGR 2013-2018 .......................................................................................... 12
Figure 3. SWOT Analysis ......................................................................................................................... 13
Figure 4. Chile and Germany´s Cultural Compass ................................................................................... 18
Figure 5. Colombia and Germany´s Cultural Compass ............................................................................ 10
Figure 6. Imports of Medical Services and Health Supplies .................................................................... 12
Figure 7. Mexico and Germany's Cultural Compass ................................................................................ 51
Figure 8: Mexico's International Trade of Medical Devices 2005 - 2013 (Million USD) .......................... 7
Figure 9 . Medical Device Exporters ........................................................................................................ 62
Latin America Market Research………………………………………….
4
INTRODUCTION
Background
Biofeedback Motor Control (BfMC) is a German company dedicated to design and manufacture
computer-supported training machines and devices for prevention, therapy, rehabilitation and
conditioning of the musculoskeletal system. The products can be employed in physiotherapy practices,
rehabilitation clinics, health and research centers; as well as in occupational medicine, sports medicine
and military medicine. BfMC products can be currently found in more than a dozen countries in Europe
and Asia, standing out for its unique characteristics related to functionality, design and quality
(Biofeedback Motor Control, 2015)
The company is interested in introducing these devices into the Latin American market. For this reason,
this report was designed as an aid to develop a market entry strategy in the mentioned region. Each
section relates to an important issue accountable to decide on the best markets for the company's
product.
This document first presents a description of the Latin American region from an economic perspective.
Each of the countries and islands were taken into account when defining the best markets for
Biofeedback Motor Control. After filtering the countries according to economic indicators, a deeper
research related to health and the medical field was made.
Six countries were selected in order to acquire a more profound understanding of the feasibility of doing
business in these markets. In this stage, the advantages and disadvantages of exporting medical device
to these markets were identified. Thereafter, a recommendation of three countries with the best
scenarios for Biofeedback Motor Control was made; followed by a detailed description of economic,
social, political, legal and business environment for exporting medical devices.
Finally, this document contains a list of possible distributors of Biofeedback Motor Control devices for
each of the three countries selected as well as a description of activities where the company can
participate to enter the market and create a network in the region. Through this market research it is
expected to support Biofeedback Motor Control’s managers and owners in the achievement of their
international marketing objective.
Latin America Market Research………………………………………….
5
COUNTRY EVALUATION
Latin America Market Research…………………………………………. 6
COUNTRY EVALUATION
Description of the research
This market research was developed due to the interest of the top management from Biofeedback Motor
Control to start exporting activities in Latin American Region. The main interest is to understand the
different markets in order to prevent costly mistakes provoked by a wrong selection of countries; as well
as to get insights of these markets that would help the implementation of the right market-entry strategy.
Since the company is not familiar with the market in this region, this report will provide a wide
understanding of doing business in the area, as well as possible risks that might threaten the
development of a business transaction in the different countries.
It is important to mention that this research was focused on medical device industry in each country
selected, taking into consideration different variables that will be further explained.
OBJECTIVE OF THE RESEARCH
Identify the preeminent markets for medical devices produced by Biofeedback Motor Control in
Latin America.
Methodology
This research was based on the information gathered from sources that already existed, also known as
secondary data, such as market reports, government sources and statistical data from the countries.
There are different factors that might influence a company's choice of markets such as trade agreements,
type of government, culture, competitiveness, market size, cost of developing the market, among others.
Screening of the Countries
Related to this research a potential market criteria was selected in order to filter the different countries
and determine the best market for BfMC. A total of 46 countries of America divided in four regions
were identified as potential markets for the company. A map of America can be found in Annex 1 and a
complete list of the countries in Annex 2.
Latin America Market Research…………………………………………. 7
The first analysis determined the exclusion of several countries due to market size (Caribbean Region,
Central America, French Guiana, Guyana and Suriname), political situation (Venezuela) or disinterest
on the market (Canada).
Thereafter, a list of ten countries was used to further research different economic indicators that were
later evaluated in order to define the top three countries with better conditions for BfMC to make
business. The countries analyzed in this stage were: Argentina, Bolivia, Brazil, Chile, Colombia,
Ecuador, Mexico, Peru, Uruguay and Paraguay.
After gathering the information on these indicators for each country, the data was graded in a scale of 1
to 5 (being 5 the best evaluation) to facilitate a ranking of the indicators. Finally, a set of variables was
defined and weighted according to the importance of the indicator for the purpose of this research (see
Annex 3 for Variables and Weights). The indicators evaluated in this stage were (World Bank, 2015a):
Table 1 . Market Research Indicators and Description
Business Environment
Variable: Attitude toward foreign
investors and profit
Trading Across Borders
Variable: Attitude toward foreign
investors and profit
Time to import (days)
DOING
BUSINESS
REPORT
Variable: Bureaucratic Delays
Number of documents to import
Variable: Bureaucratic Delays
Cost to import (USD per
container)
Indicates better, usually simpler, regulations
for businesses and stronger protections of
property rights.
Measures the time and cost (excluding tariffs)
associated with exporting and importing a
standardized cargo of goods by sea transport.
The time for importing recorded in calendar
days. Starts from the moment the stage is
initiated and runs until it is completed.
Accounts all documents required by law or
common practice by relevant agencies—
including government ministries, customs
authorities, port authorities and other control
agencies—per export and import shipment.
Cost measures the fees levied on a 20-foot
container in U.S. dollars. All fees charged by
government agencies and the private sector to
Latin America Market Research…………………………………………. 8
Variable: Bureaucratic Delays
a trader in the process of exporting and
importing the goods are taken into account.
GDP Growth 2010-2014
Annual percentage growth rate of GDP at
market prices based on constant local currency.
Variable: Economic Growth
GDP (USD)
Variable: Economic Growth
Official exchange rate (LCU per
US$, period average)
Variable: Currency Convertibility
Inflation, GDP deflator
(annual %)
Variable: Monetary Inflation
WORLD
BANK
Imports of Goods and Services
(% GDP)
GDP at purchaser's prices is the sum of gross
value added by all resident producers in the
economy plus any product taxes and minus any
subsidies not included in the value of the
products.
Official exchange rate refers to the exchange
rate determined by national authorities or to
the rate determined in the legally sanctioned
exchange market.
Inflation as measured by the annual growth
rate of the GDP implicit deflator shows the
rate of price change in the economy as a
whole.
Imports of goods and services represent the
value of all goods and other market services
received from the rest of the world.
Variable: Attitude toward foreign
investors and profit
Government Effectiveness
(World Bank, 2015i)
Variable: Bureaucratic Delays
Political Stability
Variable: Political Stability
Regulatory Quality
Variable: Enforceability of
Contract
Captures perceptions of the quality of public
services, civil service and the degree of its
independence from political pressures, policy
formulation and implementation, and the
credibility of the government's commitment to
such policies.
Measures perceptions of the likelihood of
political instability and/or politically motivated
violence, including terrorism.
Perception of the ability of the government to
formulate and implement sound policies and
regulations that permits and promote private
sector development.
Latin America Market Research …………………………………………
7
Health Expenditure (% of GDP)
Variable: Industry Indicator
INDUSTRY
SPECIFIC
INDICATORS
Medical Device Market CAGR
in USD terms (2018)
The sum of public and private health
expenditure. It covers the provision of health
services (preventive and curative), family
planning activities, nutrition activities, and
emergency aid designated for health but does
not include provision of water and sanitation.
Medical Device Industry growth until the year
2018.
Variable: Industry Indicator
Source: Authors
After gathering the data and weighting the indicators a final ranking was generated according to the
methodology explained before (see Annex 4, 5 and 6 for complete data). The final ranking is:
CHILE
URUGUAY
MEXICO
PARAGUAY
COLOMBIA
PERU
BRAZIL
ECUADOR
ARGENTINA
BOLIVIA
The complete ranking with the final evaluation for each country can be reviewed in Annex 7.
Latin America Market Research …………………………………………
8
MEDICAL DEVICE MARKET
Latin America Market Research …………………………………………
9
MEDICAL DEVICE MARKET
Latin America
According to Global Health Intelligence, 2014, there are over 16.000 hospitals in America Latina, two
thirds of which are located in Brazil and Mexico. These can be considered attractive markets for
companies selling medical devices due to their relative geographic concentration, number of hospital
beds and degree of specialization.
With the exception of Brazil, most countries in Latin America have little-to-no local manufacturing of
medical devices or medical technology. Global Health Intelligence (2014) reported over $10 billion in
imports of medical devices in Latin America, 75% of which were accounted by Mexico, Brazil,
Argentina and Colombia.
Despite the opportunities, few global medical device manufacturers have
taken the lead on making
Latin America a priority. As such, the market is generally highly concentrated with a few players
holding a cornerstone to
the industry. Local R&D is weak and manufacturing is generally limited to
second-generation products, by fear of piracy or intellectual property infringement.
Consequently, the region remains largely dependent on imports for more sophisticated products (Global
Health Intelligence, 2014).
The largest medical device market in terms of size is Brazil, followed by Mexico, Venezuela and
Colombia. While Brazil has a strong and healthy domestic industry, most regions in Latin America are
dependent on device imports. Countries like Chile, Argentina and Brazil import a significant number of
high-tech medical devices, while Venezuela, Mexico and Peru import more consumable medical devices
(Qmed, 2013).
The following figure shows the size of medical device imports in several countries:
Latin America Market Research ………………………………………… 10
Figure 1 . Medical Device Imports by Country
Source: Global Health Intelligence (2014)
As mentioned before, the number of hospital beds is a good indicator to determine the size of a market.
Therefore, the following table shows the number of hospital beds per 1.000 people, including inpatient
beds available in public, private, general, and specialized hospitals and rehabilitation centers for the
three main markets in Latin America for medical devices compared to Germany.
Table 2 . Hospital Beds vs. Population
Country
Hospital Beds
Population
Germany
Chile
8,2
2,1
80,854,408
17,508,260
Mexico
1,5
121,736,809
Colombia
1,4
46,736,728
Source: World Bank, 2013
At the same time the number of hospital beds per country is given as estimation of healthcare capacity
and to provide a wider idea of the market size. The following table shows the mentioned data:
Latin America Market Research ………………………………………… 11
Table 3 . Market Size Summary
Total Hospitals
Total Hospital
2015**
Beds***
Chile
17,363,894
420
34,829
Colombia
46,245,297
2,400
31,640
Mexico
120,286,655
3,900
131,624
Germany
80,854,408
1,980
500,686
Source: *CIA World Factbook, **Global Health Intelligence, ***Countries´ Ministry of Health
Country
Population 2014 est.*
Medical devices stand out because demand for innovative, high tech solutions is largely driven by the
private sector — in contrast to other types of healthcare expenditures, which are more evenly balanced
between the private and public sector. With over 16,000 hospitals in the region, Latin America is an
attractive market for many foreign manufacturers (Global Health Intelligence, 2014).
According to Espicom Business Monitor International (2015), the compound annual growth rate of the
medical device market from 2013 until 2018 for Mexico, Colombia and Chile exceeds the indicator rate
of Germany in more than 6% in US dollar terms, as shown in the following figure:
Figure 2 . Medical Device CAGR 2013-2018
Source: Espicom. Business Monitor International
Finally, the following SWOT Diagram provides information from the top three countries in the ranking.
This is general data that will be further analyzed and discussed in the next section of the report.
Latin America Market Research ………………………………………… 12
Figure 3. SWOT Analysis
Source: Espicom. Business Monitor International
Latin America Market Research ………………………………………… 13
CHILE
Latin America Market Research ………………………………………… 14
CHILE
General Country Information
Chile is a republic located in South America, bordering the Pacific Ocean to the west, Peru to the north,
Bolivia to the northeast and Argentina to the east (see Annex 8 for a Map of Chile). The official name of
the country is Republic of Chile and its capital city is Santiago. The national territory has a total area of
756,102 square km, making it the 38th largest country in the world (CIA World Factbook, 2015a). The
country is administratively divided in 15 regions and has a total population of 17,508,260 as of July
2014 (CIA World Factbook, 2015a). The official language of the country is Spanish.
Around one third of the country’s economy relies on exports of goods and services and the other three
quarters rely on commodity exports. Only the export of copper accounts for 19% of the total country’s
revenues. Chile’s industry sector is the strongest in its economy representing 35.5% of its GDP (CIA
World Factbook, 2015a). The main products that belong to this sector are lithium, copper, iron, steel,
cement, foodstuffs, fish processing, wood and wood products, transport equipment, and textiles.
Country Economic Indicators
Chile is considered the fifth largest economy in Latin America and when globally compared it ranks as
44th strongest economy in the world (CIA World Factbook, 2015a). According to the World Bank
(2015c), Chile is the 41st easiest country to do business with. It reported a drop of two points in the
classification when compared to the 2014 report. In addition, within the Latin American region, Chile
has performed the easiest to trade across borders, followed by Mexico, Peru, Colombia, Brazil and
Argentina respectively (World Bank, 2015c). Regarding import procedures in Latin America, Chile is
ranked as the second best in terms of import documentation (5 documents) and days to import (12 days),
only after Mexico that leads with 4 documents and 11.2 days (World Bank, 2015c). On the other hand,
Chile has the lowest import cost of the region with approximately EUR 785 per container (World Bank,
2015b).
In terms of GDP, Chile’s was worth USD 258.1 billion in 2014 (World Bank, 2014a). The GDP annual
growth rate for the year 2014 was estimated at 1.9%, a low growth when compared to the previous year
that had 4.2% of annual growth. For the period of 2010-2014, total economic growth in the country
averaged 4.64% (World Bank, 2015d).
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Total GNI per capita in current international dollars amounted to $14,520, while the GNI in Purchasing
Power Parity (PPP) dollars amounted to $22,333.1 as seen in Table 4. Further, the inflation annual rate
in Chile has averaged 4.06% during the period of 2010-2014. During the year 2014 it was recorded at
5.4% (World Bank, 2015f).
From Chile’s total economic available population, 7.973 thousand have been reported to be employed,
whereas the unemployed have been reported to be 556 thousand. The unemployment rate has been
estimated at 6.5% as of June 2015. (Trading Economics, 2015a) In addition to the above-mentioned
indicators, table 4 provides further important economic indicator of Chile:
Table 4 . Chile´s Economic Indicators
Source: World Bank
Political Environment
The Republic of Chile is a unified state with 16 administrative regions, which are being ruled by one
President. For the current term, President Michelle Bachelet began her second term in March 2014
(Overseas Business Risk, 2015a). The Chilean constitution separates clearly 3 powers: the Executive
power being under the charge of the President of Chile, the Legislative power constituted by the Senate
Latin America Market Research ………………………………………… 16
and Chamber of Deputies, and the Judiciary constituted by the Supreme Court, Appeals Courts and local
systems (Overseas Business Risk, 2015a).
The country’s rule of law is strong, and a free press exists in the country. The current government is of a
left-wing ideology, focusing mainly in the reduction of inequality in the country (Overseas Business
Risk, 2015a).
Social and Cultural Environment
According to The Hofstede Center (2015a), Chile’s social culture is considered low in terms of power
distance. This means that the culture and society is characterized by being of a hierarchical order where
rigid social classes exist. Privileges prevail for those that hold power, which is contrary to the German
society. At the same time, as in other Latin American countries, the Chilean society scores low as an
individualistic society, contrary to the German society, which is truly individualistic. In Chile, blue and
white collar workers are said to look for autonomy and do not hesitate to change employers when
needed (The Hofstede Center, 2015a).
In the dimension of masculinity, the same source indicates that Chile’s society scored low, which means
it is considered a feminine society or a society that cares much for others. As a feminine society, people
tend to “work in order to live”. This is opposite to the German society, which is considered as masculine
in the sense that people “live in order to work”. Both men and women show modest behaviors or
attitudes. At the same time, the Chilean people place great value on interpersonal links and they are
searching for approval within groups. Great value is given to equality, solidarity and quality in their
working life.
The same source indicated that in terms of uncertainty avoidance, as in many Latin American countries,
the Chilean society presents a need of legal systems and rules in order to have a structured life.
Corruption issues are rather low in the country and there exist a strong dependence in authorities (The
Hofstede Center, 2015a).
Lastly, The Hofstede Center (2015a) considers that indulgence is high in Chilean society, which means
the society is willing to go for their impulses and desires in order to enjoy life. Tendency toward
optimism exists and the people tend to have a positive attitude. A strong importance in free time and
acting as they please have a great value in Chilean society.
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Figure 4. Chile and Germany´s Cultural Compass
Source: adapted from The Hofstede Center (2015a)
General Business Environment
As previously mentioned, Chile ranks as the 41th easiest country to do business with among 189
evaluated economies (World Bank, 2015c). In addition, in terms of competitiveness the World
Economic Forum (2014) ranked Chile as the most competitive country in Latin America and number 34
in the world. With the highest GNI per capita in the Latin American region, Chile is considered a very
liberal and open market economy with solid macroeconomic stability (Overseas Business Risk, 2015a).
Strong institutional systems, low levels of corruption as well as an efficient government are some of the
reasons of the country’s competitiveness. In addition, the country is considered to have well-functioning
markets, as well as low levels of public debt (World Economic Forum, 2014) and openness to foreign
trade (World Economic Forum, 2014).
As of 2015, Chile has 24 FTAs with over 50 countries, including with the European Union, United
States of America and China (Dirección General de Relaciones Económicas Internacionales, 2015).
Latin America Market Research ………………………………………… 18
Medical Device Market
Market Value
In Chile a medical device is defined as any instrument, apparatus, appliance, material or article,
including software, used alone or in combination, and defined by the manufacturer to be used directly in
humans, provided their principal intended action in the human body does not reach pharmacological,
immunological or metabolic means; for the purpose of diagnosis, prevention, monitoring, treatment or
alleviation of disease, injury or disability; for research or replacement or modification of the anatomy or
of a physiological process, or control of conception (Public Health Institute, 2015).
Based on the above definition, Espicom (2015) considers the medical device market in Chile as small,
however in terms of per capita spending it is first in Latin America. According to this same source, the
medical device market in Chile has been growing steadily since 2010 and the CAGR of the market is
forecasted as 10.9% for the period of 2013-2018, reaching USD 1.4 billion by 2018. The main reason
for such growth is a recent health reform that the country is conducting, which is expected to boost
demand of medical devices and equipment (Espicom, 2015).
The manufacturing of medical devices in Chile is limited, thus the demand is fulfilled via imports, being
the United States the main supplier followed by Germany, Holland, France and Japan (Hartwig J. &
Quirland C., 2009).
In terms of market value, imports of medical devices in Chile have increased since 2004 from USD 231
million to USD 462 million in 2008 (Hartwig J. & Quirland C., 2009). According to this source, the
medical device demand includes a wide range of devices like orthopedic, prosthetic and dental devices.
Furthermore, the demand mainly originates from the public sector and CENABAST. At the same time
the private sector also plays an important role in the purchasing of medical devices (Hartwig J.
& Quirland C., 2009).
Market Size – Hospitals
According to the Chilean’s Instituto Nacional de Estadísticas (2012a), as of 2010 the total number of
hospitals from the public sector were 231 with a total capacity of 28,062 hospital beds. The private
sector counted with 147 hospitals with a total capacity of 6,767 hospital beds. In addition, total hospital
Latin America Market Research ………………………………………… 19
beds per 1,000 population has been reported as 1.5 (CIA World Factbook, 2015c) Table 5 provides a
summary of the market size in terms of hospitals.
Table 5 . Market Size- Hospitals
Source: Instituto Nacional de Estadística (2012ª)
Nature of Demand for the Company’s Products
According to the Chilean’s Instituto Nacional de Estadísticas (2012b) there are 2,068,072 people with
disability in Chile, which represent 12.9% of the total population. According to the same source, the
most frequent disability found on a national level is related to mobility, where 35.4% of the 2 million
people with disability reported to have mobility limitations (Instituto Nacional de Estadísticas, 2012b).
The same source states that 51% of people with disability ages between 30 to 64 years old, while 35.1%
ages 65 years old or older. Furthermore, 6 out of 100 people with disability have had rehabilitation
services during the last year. Approximately 134,000 people (6,49%) have received rehabilitation
therapies (Instituto Nacional de Estadísticas, 2012b). Lastly, 75.7% of the total population with
disability received treatment in the public sector, while the rest (24.3%) received treatments in the
private sector.
Regulatory Environment
According to the Public Health Institute (2015), the medical devices in Chile are regulated by the Public
Health Institute (ISP in Spanish) under the Health Code article 101, incorporated through the law 19.497
and the Products Control and Elements of Medical Use Regulation No. 825/98. According to article 101
from the Health Code, all medical devices shall comply with the standards and quality requirements
applicable to them according to their nature weather they are to be manufactured, imported,
commercialized or distributed in Chile (Public Health Institute, 2015). The certification for the medical
Latin America Market Research ………………………………………… 20
devices must be made by a corresponding entity authorized by the National Health Institute of Chile
(Public Health Institute, 2015).
According to the Products Control and Elements of Medical Use Regulation No. 825/98, the medical
devices are grouped into the following 4 types based on the level of risk associated with their use:
•
•
Class I: includes devices that have a very low level of risk.
•
Class III: includes devices that have a high level of potential risk.
•
Class II: includes devices that present a moderate level of risk.
Class IV: includes devices considered the most critical in regard of risks.
Based on the type, medical devices must comply with the following requirements in order to be verified:
Class I
•
Table 6 . Classification of Medical Devices
Product, manufacturer and distributor identification, specifying their characteristics,
including the package labeling, internal instructions and batch number with code,
•
and description of their operation.
•
chemical procedures and biological evaluation, if applicable.
•
and controls; expiration date and storage conditions.
Statement of materials: list of parts and raw materials used in the manufacturing,
Sterilization and storage background, if applicable respective sterilization methods
•
National or foreign background that supports product quality and / or production.
•
Republic of Chile, and when missing, of the ones approved by the Health Ministry.
Evaluation of the operation, if applicable, according to the official norms of the
Certificate for export purposes granted in the country of origin, authorized by the
corresponding state authority and duly legalized, in the case that the medical device
Class II
Class III
•
•
•
is imported into Chile.
All requirements of Class I
Manufacture certificate according to quality system: quality assurance model in the
production, installation and service, NCh-ISO 9002 or GMP.
All requirements of Class I.
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•
Class IV
•
Scientific literature that supports the product.
•
product.
•
Studies conducted by the manufacturer to prove the effectiveness and safety of the
Manufacture certificate of quality system: model of quality assurance in the design,
development, production, installation and service, NCH ISO 9001 or GMP.
•
All requirements of Class III.
•
Study of all the risks inherent in the use of the device.
•
Studies conducted in a representative group of patients.
Biological Studies by the manufacturer with respect to the device.
Source: Public Health Institute (2015)
Market Entry
To enter the Chilean market it is advisable to do so through a local representative or distributor,
particularly if the company is tendering in the public sector (Hartwig J. & Quirland C., 2009).
If the company is interested to supply to the public sector, the demand is channeled through the
CENABAST program (Central de Abastecimiento or Supply Center in English) that concentrates almost
80% of demand and which uses the bidding mechanism (Hartwig J. & Quirland C., 2009).The basic
requirement that is needed from this entity is that every supplier to the state is represented locally.
Therefore, having a local partner is strongly recommended (Hartwig J. & Quirland C., 2009).
Potential Distributors
The potential distributor is provided below:
Cristian Camus V. Ltda: importer and distributors of medical equipment oriented towards rehabilitation.
Website: http://www.ccamusv.cl/empresa.html
In addition, it is worth noting the main buyers of medical devices in Chile. The main buyers include the
big clinics. The most important ones belong to the BANMEDICA group which total share is close to
20% (Hartwig J. & Quirland C., 2009). Thus, potential buyers include clinics belonging to this group:
•
•
Clínica Dávila: http://www.davila.cl/
Clínica Santa María: http://www.clinicasantamaria.cl/
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•
•
Clínica Vespucio: http://www.clinicavespucio.cl/
Bio-Bio: http://www.clinicabiobio.cl/
Along with the BANMEDICA Group, the following clinics contribute to 74% of all medical device
purchases in the country (Hartwig J. & Quirland C., 2009):
•
•
•
Clínica Alemana: http://portal.alemana.cl/wps/wcm/connect/internet/home
Clínica las Condes: http://www.clc.cl/
Clínica Indisa: http://www.indisa.cl/indisaweb/index.php
General Information for Importers
As with the other two previous countries, Chile has a FTA with the European Union, which represents
an advantage to potential European exporters. Particularly for the tariff code 95069110 – Exercising
apparatus with adjustable resistance mechanism, there is no import tariff to be paid.
With regard to import procedures, the following are needed:
1. Bill of lading
2. Commercial Invoice
3. Customs import declaration
4. Packing list
5. Technical standard/health certificate
In addition, the time to import to Chile takes on average 12 days, which is below the regional average of
19 days (World Bank, 2015b).
Competitors
The market is dominated by branches of foreign companies and by Chilean companies that represent
important international brands (Hartwig J. & Quirland C., 2009). In terms of suppliers there are
approximately 110 companies in Chile that supply mainly all medical devices to the country (Hartwig J.
& Quirland C., 2009). Among the most important suppliers, there is multinationals such as General
Electric Medical, Medtronic, Siemens and Philips (Hartwig J. & Quirland C., 2009).
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7
Market Risks
According to the World Economic Forum (2014) on its Global Competitiveness Report, the most
problematic factors for doing business in Chile are related to governmental issues instead of corruption,
violence or crime. Some of the problematic issues include restrictive labor regulations, inadequately
educated workforce, inefficient government bureaucracy, insufficient capacity to innovate and tax rates
(World Economic Forum, 2014). Compared to Mexico and Colombia, Chile possesses a relatively low
environment for crime and corruption. Based on the Global Competitiveness Report’s indicators of
irregular payments and bribes, Chile scored high (5.7) which means it is not so common for firms to
make undocumented extra payments or bribes. The indicator is measured from 1 (very common) to 7
(never occurs). Furthermore, the business costs because of crime is relatively moderate in Chile (4.7). In
addition, Transparency International (2014) in its Corruption Perceptions Index scored Chile with 73
points, which is considered as a clean country in terms of corruption.
Further recommendations
As previously mentioned, trade fairs are important places where companies can acquire future
distributors. In this regard, the Expo Hospital fair: http://www.expohospital.cl/ING_index.php, taking
place in Chile is an important meeting point for medical industry. In addition, it is always useful to
contact
ProChile
http://www.prochile.gob.cl/,
or
the
Chilean
Embassy
in
Germany:
http://www.echile.de/index.php/es/ in order to acquire potential contacts and distributors in Chile.
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COLOMBIA
Latin America Market Research ………………………………………… 25
COLOMBIA
General Country Information
The Republic of Colombia is a country located in South America, bordering the Caribbean Sea, between
Panama and Venezuela, and bordering the North Pacific Ocean, between Ecuador and Panama. Its
national territory has an area of 1.138 mill square kilometers, placing it in the 26th position in the world
(see Annex 9 for a Map of Colombia)
Colombia is the third most populous country in Latin America. An approximate of 47.66 million
(December 2014 est.) people lives in this country, mostly in the capital Bogotá. This Spanish speaking
country is divided in 32 departments and 1 capital district (CIA World Factbook, 2015b).
Colombia is the world's fourth largest coal exporter and Latin America's fourth largest oil producer. Its
GDP (purchasing power parity) is $642.7 billion (2014 est.).
Colombia produces coffee, cut flowers, banana, rice, tobacco, and corn, among other products. The
country´s industry is mainly dedicated to textiles, food processing, oil, clothing and footwear,
beverages, chemicals and cement (CIA World Factbook, 2015b). Main imports for Colombia are:
machinery and transport equipment, manufactured products, chemicals and fuel and mineral lubricants.
Its main trading partners are United States and China (Trading Economics, 2015c). In May 2013,
Colombia was invited to start OECD negotiations.
General Country Economic Indicators
Colombia has demonstrated advances in the world´s rankings due to an increase in its level of
technological adoption and the development of its infrastructure. However, more progress needs to be
made with infrastructure, as this is still the second most problematic factor for doing business in
Colombia, after the high level of corruption (World Economic Forum, 2015).
The inflation rate in Colombia was recorded at 4.41% in May of 2015; for the following months this
rate´s forecast varies from 4.83% to 5.15% (Trading Economics, 2015b).
As mentioned before, the estimated population is 47.66 million of which 21.368.000 Colombians are
employed. As of April 2015 the unemployment rate was 9.5%.
The country has been ranked 34th in the World Bank’s Doing Business assessment for 2015, a major
move up of 9 places on the previous year. Colombia is the top country in Latin America (and sixth in the
world) for investor protection according to the World Bank (Overseas Business Risk, 2014)
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The country is a regional hub (6 hours flight to all other Latin American capitals and 3 hours to Miami),
with duty-free access to the other Andean nations, Mercosur and Chile; and has a tradition of stable
economic growth, democratic government and prudent economic management in a region that has seen
a number of economic crises (Colombia has never defaulted on its sovereign debt) as indicated by the
Overseas Business Risk (2014).
In the first trimester of 2015 Colombia´s GDP grew 2.8% in comparison to the same time period in
2014. This growth impacted mostly areas like commerce, restaurants and hotels with 5.0%; construction
with 4.9% and financial institutions, real state and services (B2B) with 4.4%. (DANE, 2015). Foreign
Direct Investment reached US $16bn in 2013, focusing mostly in the extractives sector (mining and oil
& gas), however diversification has been showing growth in service centers, hotels and financial
services (Overseas Business Risk, 2014).
Colombia’s current environment stands out as a favorable destination due to several reasons like the
Government’s investment in infrastructure, reduced limitations for foreign direct investment, and
advantages for investors through different free trade zones.
Colombia is one of the most open markets in Latin America as it has thirteen Free Trade Agreements
currently in force, including with the United States, the European Union, Mercosur, the Caribbean
Community, South Korea and Mexico. There are also five-signed agreement waiting to enter into force,
and three more under negotiation (Overseas Business Risk, 2014).
GDP growth will slow in 2015 to 3% but will pick up thereafter, helped by improvements to the
business environment, sound macroeconomic management and investment growth (The Economist,
2015).
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The following table presents the most important economic indicators of Colombia:
Table 7 . Economic Indicators of Colombia
Indicator
Gross Domestic Product (GDP)
Gross National Income (GNI) per
Last
Period
Source
$377,7 billion
2014
World Bank
$7,780
2014
World Bank
$12,600
2014
World Bank
4,46%
2010 - 2014
World Bank
8.8%
3615.19 COP
2015
August 2015
Trading Economics
InforEuro
-1.97 USD bill
July 2015
Trading Economics
capita in current USD
Gross National Income (GNI) per
capita in PPP
Average Inflation Rate
Unemployment rate
Exchange Rate EUR/Colombian Peso
Trade Balance
Source: World Bank
Political Environment
Colombia has suffered from an internal conflict for a number of years. This arose when left-wing groups
took to armed struggle in the mid-1960s. The most known of these groups is the Revolutionary Armed
Forces of Colombia (FARC). The conflict has become increasingly complex as paramilitary groups
emerged to defend the interests of large landowners against the rebels. Moreover, the ideological
conflict has been largely overtaken by a struggle for control of the drugs-trafficking business (Overseas
Business Risk, 2014). This conflict is no longer a significant issue for businesses operating in
Colombian cities, however, there is still a potential threat to safety when it comes to rural areas.
The current president, Juan Manuel Santos, will seek to conclude peace negotiations with FARC
guerrillas and address other long-standing social ills. The process has undergone setbacks after rebels
killed soldiers in April, and the guerrillas ended a unilateral ceasefire in May, but it is expected talks to
continue.
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Social and Cultural Environment
According to The Hofstede Center (2015b), Colombia’s society scores 67 in power distance indicator.
This is a high evaluation that shows this is a society that believes inequalities amongst people are simply
a fact of life. This is a reality accepted in all stratums, so a union leader will have a lot of concentrated
power compared to his union management team, and they in turn will have more power than other union
members. A similar phenomenon will be observed among business leaders and among the highest
positions in government.
Colombia lies amongst the most collectivistic cultures in the world, scoring 13 in individualism,
meaning people belong to ‘in groups’ that take care of them in exchange for loyalty. Since the
Colombians are a highly collectivistic people, belonging to an in-group and aligning yourself with that
group’s opinion is very important.
Colombia is a Masculine society – highly success oriented and driven. Colombians are competitive and
status-oriented, yet collectivistic rather than Individualist. People seek membership in groups, which
give them status and rewards linked to performance, but they often sacrifice leisure against work, as
long as this is supported by group membership and by power holders.
In regards to uncertainty avoidance, an indicator related to the way the society deals with future
uncertainty, Colombia is a nation that seeks for mechanisms to avoid ambiguity; they express their
emotions openly, and keep rules for everything. However, having rules does not assure the compliance
of them, since the ‘in-groups’ will decide it these rules are applicable or not to them according to their
interests. In work terms this translates in detailed planning that may not necessarily be followed in
practice.
Finally, the Colombian society is considered indulgent, since they show disposition to realize their
impulses and desires regarding having fun. They have a positive attitude and leisure is important for
their lives (The Hofstede Center, 2015b).
The following figure shows a comparison of the indicators mentioned above between Colombia and
Germany. The main differences between both societies are related to long-term orientation,
individualism, indulgence and power distance.
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9
Figure 5. Colombia and Germany´s Cultural Compass
Source: adapted from The Hofstede Center (2015a)
General Business Environment
Colombia signed a free trade agreement along with Peru and Ecuador in 2012 with the European Union
known as the European Union Andean Free Trade Agreement; this was provisionally applied with
Colombia since August 2013. This agreement forecasts an increase in the stability and predictability of
the trading environment in the country. Most exports from the European Union consist on manufactured
goods, machinery and transport and chemical products (European Commission, 2015).
Since May 2013, Colombia was invited to start OECD accession negotiations and its fully accession is
planned for 2018. In relation, the Government is committed to work on a better economic environment
improving its tax system’s competitiveness and capitalize the peace dividend (European Commission,
2015).
In regards to transparency, the country ranked 94th in the 2014 Transparency International corruption
perception index, highlighting the political problems more than the business ones; however these are
more related to construction projects and local government authorities, which are being brought to
prosecution (Overseas Business Risk, 2014). Nevertheless, the World Economic Forum's Global
Competitiveness Report 2012-2013 identified corruption, inefficient government bureaucracy and
Latin America Market Research ………………………………………… 10
inadequate supply of infrastructure as the major problems for developing business in the country. The
World Bank and IFC Enterprise Surveys 2010 indicate that companies report bribes or gifts as expected
when interacting with tax inspectors, when bidding on public tenders and when applying for various
licenses and permits (Business Anticorruption, 2015).
Medical Device Market
Market Value
According to the World Bank Colombia’s GDP for Medical Industry (GDP % of Government Spending
on Health Care) is 6,8%.
Healthcare infrastructure is adequate in urban areas, however it’s in need of renovation. Regarding
healthcare it is still not universal, though it covers 80% of the population, and the per capita health
expending is considered low: US $479 in 2013, while expenditure on medical equipment is around
US$24 per person (Espicom Business Intelligence, 2015). Nevertheless, Colombia has one of the most
extensive insurance systems and medical financial protection in the region.
In 2012, Colombia imported medical equipment and supplies valued at US$865.2mn, mostly done by
the private sector, which is more stable within the medical industry. The medical device market, mostly
concentrated in the capital Bogotá, depends on imports especially for high tech sectors although there
are a few multinational companies manufacturing in the country (Espicom Business Intelligence, 2015).
The following figure presents the details of imports from 2008 to 2012. Imports of medical devices and
health supplies from Germany represent around 13% of the total, becoming the second main
commercial partner for Colombia.
Latin America Market Research ………………………………………… 11
Figure 6. Imports of Medical Services and Health Supplies
Source: Foro Internacional de Dispositivos Médicos-Andi (2013)
Since 2012 with the FTA, 96% of US medical equipment exported to Colombia has received duty free
treatment, and other FTAs with Europe, South Korea and Canada will increase the competition to US
manufacturers. The strongest competitors are currently China, Germany and Japan (Export.gov, 2015).
The highest level of imports of medical equipment and supplies was reported in 2011 and valued at
US$914 mill.
Market Size- Hospitals
According to America Economia Intelligence, in 2012 Colombia had seven of the twenty best hospitals
and clinics in Latin America. In fourth place is the Hospital Fundación Santa Fe in Bogota, in seventh,
eighth and ninth place are the Fundación Valle del Lili in Cali, Fundación Cardioinfantil in Bogota, and
Fundación Cardiovascular de Colombia in Bucaramanga (Export.gov, 2015).
The Colombian Ministry of Health reported in 2014 a total of 3,620 hospitals and clinics in the country,
75% of hospitals are public and 25% are private; with a total of 74,082 hospital beds (Ministerio de
Salud, 2015a). As of 2012 the World Bank accounted a total of 1,5 hospital beds per 1.000 inhabitants.
The following table describes the market size in terms of hospitals:
Latin America Market Research ………………………………………… 12
Table 8 . Market Size- Hospitals
Number of Hospitals in
the Public Sector
Number of Hospitals in
the Private Sector
Hospital Beds per 1,000
inhabitants
2.715
905
1,5
Source: World Bank and Colombian Ministry of Health
Colombia is also promoting the country as a destination for health and medical tourism, due to its
reputation as an innovator and frontrunner in health services, and an attractive destination for medical
treatments, which is an market opportunity since hospitals need to upgrade their facilities and invest in
equipment renewal.
Nature of Demand for the Company’s Products
According to the Ministry of Health in Colombia there are 1.062.917 people registered with disability,
representing 2,3% of the total population. This group is formed mostly by adults over 55 years old
(Ministerio de Salud, 2015b).
The National Administrative Department of Statistics -DANE- detailed the most common disabilities as
blindness, deafness, muteness, delay or mental deficiency and paralysis or loss of limbs.
In 2005, a national survey determined that of every hundred Colombians with limitations 29,3 have
permanent problems to walk or move and 14,7 have permanent limitations to use their arms and hands.
Regulatory Environment
In Colombia, a medical device is defined as an instrument, apparatus, implement, machine, appliance,
implant, material or other similar item or related, used alone or in combination, including accessories
and software needed to its proper application, intended by the manufacturer, when used in humans to: a)
Diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; b) Research,
substitution or support of the anatomical structure or physiological process; c) Support and sustaining
life; d) Birth Control; e) Disinfection of medical devices; or f) Test in vitro sample derived from the
human body (Foro Internacional de Dispositivos Médicos, 2013).
Latin America Market Research ………………………………………… 13
Medical devices are required to register at “Instituto Nacional de Vigilancia de Medicamentos y
Alimentos” (INVIMA), which is the country’s medical device regulator; it is also recommended to
register under the company’s name and not the local distributor (Export.gov, 2015).
Colombia’s device classification scheme is a four-tiered system, similar to those in the European Union:
Class I, Class IIa, Class IIb and Class III. If the device is classified as Class I or IIa, the company might
qualify for an accelerated evaluation process and accomplish market entry in less time.
Registration Process
First the company needs to determine the classification of the medical device according to Chapter II of
Decree 4725/2005 of the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
Then, select an importer or legal representative (properly licensed lawyer) from the country; importers
will list themselves as owners of the registration, while legal representative will solicit a Power of
Attorney to manage the process. The third step is to obtain a Certificate of Free Sale (CFS) or
Certificate to Foreign Government (CFG) to validate the device can be legally sold in the origin
country. Afterwards, prepare registration application with detailed information about the device and
proof of quality compliance like ISO 13485; in some cases proof of testing reports and clinical data
might be requested. The application and other materials must be submitted in Spanish to INVIMA, and
an application fee must be cancelled.. Class IIb and III devices, it takes between three and four months
to review the application.. Once registered, the company can start selling the device in Colombia.
Registrations expire after 10 years, and renewals are due three months before expiration.
Market Entry
The recommended strategy to enter the Colombian market is through distributors, who will register the
devices according to the adequate legal process. To penetrate effectively the market, the company
should offer competitive pricing and financing; along with support and post-sales service. Product and
company information should be in Spanish.
If interested in becoming a supplier in the public sector, the company must follow the requirements
indicated in Article 8 of the Law of Procurement and Public Contracting (Ley de Compras y
Contrataciones Públicas) in order to register in the State’s Suppliers Registry (Comisión Ejecutiva para
la Reforma del Sector Salud, 2015).
Latin America Market Research …………………………………………
7
Potential Distributors
Biomec is a company founded in 2007 dedicated to import specialized electro medical equipment for
Computerized Analysis of Movement and Orthopedics High Technology, Physical Therapy, Sport
Medicine and Biomedic Engineering. The products they distribute are imported from the headquarters in
Italy and United Kingdom; and distributed in Latin America. Besides, the company provides post-sale
support, installation and training. They also provide personalized consulting and trainings of
Computerized Analysis of Movement in Clinical and Sport Areas in rehabilitation centers, universities
and hospitals. More information: http://www.biomec.com.co/
Equibiomedic is a company dedicated to provide support and maintenance services, and sales and rent
of biomedical equipment. The company is located in Medellín. For more information visit:
http://equibiomedic.com/
Biosistemas is dedicated to provide equipment, accessories and support services, and biomedical
equipment rental. More information in http://biosistemasing.blogspot.de/ Contact Information: Edickson
Iovanni Salgado Avilan, General Manager, [email protected]
Fisiomédica was founded in 1979 in Cali and it specializes in commercialization of equipment and
supplies for rehabilitation and physiotherapy. The company has offices in Cali and Bogotá. More
information: www.fisiomedica.com.
General Information for Importers
Colombia currently has a Free Trade Agreement with the European Union. Importers in Colombia must
comply with the following requirements:
•
•
Obtain import permits from pertinent government agencies if required.
Buy and fill out the Import Registration form. File the Import Registration form with Ministry
of Commerce, Industry and Tourism. The form requires a complete product description and
•
tariff classification.
•
Form or Import License (in the few cases when this is required).
Obtain approval from Ministry of Commerce, Industry and Tourism for the Import Registration
Other procedures must be completed with Customs Agency in order to import goods in the
country. All documents must be saved for a period of not less than five years.
Latin America Market Research …………………………………………
8
The MFN duty rate for importing 95069110 into Colombia is 15% and the sales tax is 16% (Duty
Calculator, 2015). The MFN is the simple mean most favored nation tariff rate is the unweighted
average of most favored nation rates for all products subject to tariffs calculated for all traded goods
(World Bank, 2015h).
Competitors
The main competitors in the medical device market are China, USA and Japan. There are more than 280
companies manufacturing medical devices and around 1445 companies importing all types of medical
devices (INVIMA, 2015); however specific businesses that commercialize biomedical equipment in
Colombia are:
Esaote Group is a company in the biomedical equipment sector, with a particular focus on ultrasound,
dedicated magnetic resonance, and healthcare IT software for managing the whole diagnostic process.
BTL Colombia S.A.S. is a manufacturer of medical and esthetic devices specialized in physiotherapy,
cardiology and esthetic medicine.
B. Braun Medical S.A. is located in Medellin and Bogotá, and has a brand of sports medical devices as
a combination of classical arthroscopy, navigation systems and biotechnology.
Market Risks
One of the major challenges for businesses in Colombia is corruption. The World Economic
Forum identified this as the most problematic factor for doing business in this country,
followed by inefficient government bureaucracy. In this sense, the country has been working in
simplifying the procedures and removing unnecessary administrative burdens to investors.
Though security situation has improved in recent years, there is still a threat of terrorism from
groups like the FARC and ELN (National Liberation Army).
Regarding intellectual Property, it is recommended for manufacturer and traders to patent their
inventions and register their trademarks in Colombia through a patent or trademark agent.
Latin America Market Research …………………………………………
9
Further Information
It is recommended to participate in relevant trade events to promote the products such as Meditech
Colombia, an international health trade fair, organized every two years, that gathers the key
stakeholders in the medical industry; the last edition received 10.034 visitors. It becomes a platform for
networking and a commercial showcase of products and services related to the industry.
Representative attendees include hospital and clinic managers, Directors General, financial and
administrative managers, and purchasing managers; health sector officials; and health sector service
providers.
Usual exhibitors are manufacturers and distributors of medical, surgical, dental, and clinical laboratory
equipment; hospital staffing firms; distributors and marketers of direct inputs related to the health
sector; entities administering benefit plans; and prepaid medical institutions.
The fifth edition will be held from June 28th to July 1st, 2016. For more information visit:
http://feriameditech.com/
Latin America Market Research ………………………………………… 41
MEXICO
Latin America Market Research ………………………………………… 42
MEXICO
General Country Information
Mexico is a federal republic located in North America, bordering the United States of America on the
north, the Gulf of Mexico on the east, Belize, Guatemala and the Caribbean Sea on the south-east, and
the Pacific Ocean on the west (see Annex 10. Map of Mexico). The official name of the country is
United Mexican States, and its capital being the largest city in the country is Mexico City (Distrito
Federal). The national territory has a total area of 1,964,375 sq km, making it the 14th largest country in
the world (CIA World Factbook, 2015c). The country is administratively divided in 31 states and has a
total population of 120,286,655 inhabitants as of July 2014, making it the 12th most populated country
in the world (CIA World Factbook, 2015c). The official language of the country is Spanish. Mexico’s
main productive sectors are composed of Agricultural products, which represent 3.5% of its total gross
domestic product (GDP) (CIA World Factbook, 2015c). Main agricultural crops include corn, wheat,
soybeans, rice, beans, cotton and coffee. In addition, food beverages, tobacco, chemicals, iron and steel,
oil, textiles and motor vehicles mainly drive the country’s industry.
General Country Economic Indicators
As one of the most dynamic economies in Latin America, the World Economic Forum (2014) ranked
Mexico in its Global Competitiveness report as the top sixth most competitive economy in the region
and number 53 among 144 worldwide. Particularly under the Macroeconomic Environment pilar, which
measures government budget balance, gross national savings, inflation, and government debt and
country credit, Mexico presents stability among the Latin American countries.
In terms of the country’s GDP, this one was worth $1,283 trillion in 2014, making Mexico the second
largest economy in Latin America after Brazil (World Bank, 2015g). Complementary, the economic
growth rate in the country has averaged 3.26% during the period 2010 – 2014 (World Bank, 2015g).
Particularly for the year 2013 the economic growth rate was reported at 1.10%, 2.1% in 2014 and
forecasts expect a boost in economic growth through 2017 (World Bank, 2015g). In terms of Gross
National Income (GNI) per capita in current USD amounted to $9,980 in 2014 and GNI per capita in
Purchasing Power Parity (PPP) was $16,710 (World Bank, 2015e) in 2014. Regarding employment,
from the economically active population, it was reported that at the end of March 2015, 49.8 million
people were employed, while the unemployed population amounted to 220 thousand (Trading
Latin America Market Research ………………………………………… 47
Economics, 2015d). Furthermore, according to Trading Economics (2015d), the unemployment rate as
of April 2015 was reported at 4.31%. In regard of inflation, the average rate for the 2010 - 2014 period
was reported as 3.68% and the latest estimate in July 2015 was reported as 2.74% (Trading Economics,
2015d). The exchange rate between the Euro and the Mexican Peso as of August 2015 was 1 EUR =
MXN 17.9459.
In general, the above given economic indicators are relevant for potential exporters since they help
understand the economic and commercial environment in which the company’s products are intended to
be sold. Table 7 summarizes the economic indicators along with Mexico’s trade balance.
Table 9: Mexico’s Economic Indicators
Indicator
Gross Domestic Product (GDP)
Gross National Income (GNI) per capita
Last
Period
Source
$1.283 trillion
2014
World Bank
$9,980
2014
World Bank
$16,710
2014
World Bank
3.68%
2010 - 2014
World Bank
1 EUR = MXN 17.9459
August 2015
InforEuro
June 2015
Trading Economics
in current USD
Gross National Income (GNI) per capita
in PPP
Average Inflation Rate
Exchange Rate EUR/Mexican Peso
Trade Balance
-$749
Source: World Bank
Political Environment
Mexico is a democratic country based on a Constitution, this one being the fundamental law of the
country. The country is considered as a representative republic, democratic and federal, constituted by
31 free and sovereign states in their internal regime, however governed together in a Federation. The
federal government is the one representing the United Mexican States and it is divided in three powers
Latin America Market Research ………………………………………… 48
or branches (CIA World Factbook, 2015c). The Executive branch is independent from the Legislative
branch and is represented by the President of Mexico, Enrique Peña Nieto. The Legislative branch is
represented by the General Congress and is constituted by the deputies and the senators chambers (CIA
World Factbook, 2015c). The third branch, i.e. the Judicial Power constitutes the Supreme Court of
Justice and the Electoral Tribunal of the Federal Judiciary (CIA World Factbook, 2015c).
Further, the public administration is divided in three main areas: the Federal administration, which
covers the whole country; the State administration which is centered in one state; and the municipal
administration, which refers to the local political-administrative units in each state. Each federal state
has its own government and they present the same division of powers as the Federal government:
Executive power (represented by a Governor), the Legislative power (represented by the chamber of
senators) and Judicial (represented by the Superior Court of the State).
In terms of political parties, Mexico has a multi-party system for political elections. In total there are 10
political parties (Instituto Nacional Electoral, 2015), however three of them are particularly the most
popular, those being the Institutional Revolutionary Party (PRI), which is currently the party in power;
the National Action Party (PAN) and the Party of the Democratic Revolution (PRD).
Social and Cultural Environment
Based on the Cultural Compass of The Hofstede Center (2015c) there are 6 dimensions in which a
country’s culture can be explained.
In the first dimension, which represents power distance, the Mexican society is considered to be
hierarchical. By hierarchical society the compass means that everyone has a place without justification
(The Hofstede Center, 2015c). This is contrary to the German society which tends to have a direct and
participative communication regardless of hierarchical positions. At the same time, the Mexican society
is considered as a collectivistic society. This dimension deals with people’s self-image or how it is
defined. For example, collectivistic societies see themselves as “we” and are contrary to the
individualistic societies (German society) who see themselves as “I”. In addition, collectivistic societies
tend to have a strong commitment and loyalty towards the immediate family, relatives or other
acquaintances. Mexicans prefer to maintain strong relationships where everyone takes responsibility for
members of their group (The Hofstede Center, 2015c). Compared to the Mexican society, German
society is truly individualist, in the sense that there is a strong focus on parent-children relationships,
Latin America Market Research ………………………………………… 49
while relationships with other relatives or acquaintances are rather less common. Further, the
communication in general tends to be very direct.
The Hofstede Center (2015c) additionally categorizes the Mexican society as a masculine society. A
masculine society is characterized by competition, achievement and success. In such societies, people
are “living in order to work” rather than “working in order to live”. Managers are expected to be
assertive and decisive.
In the third dimension, the same source considers the Mexican society to have a strong and high
preference for avoiding uncertainty, which means that society maintains strong codes of beliefs and
behaviors in order to avoid uncertainty and tend to be intolerant of ideas. In cultures like the Mexican,
preparation, precision and punctuality are very important and people have an urge to be busy and work
hard. This seems to be quite similar to the German culture as well.
The same source, regarding long term orientation, considers the Mexican society as a normative society,
in which people have a strong respect for traditions, less propensity to save for the future, and achieving
short-term quick results.
Lastly, the Mexican society is said to have a tendency towards indulgence. This means that people
possess a positive attitude and have a tendency towards optimism. In addition, they place a higher
degree of importance on leisure time, act as they please and spend money as they wish. This is contrary
to the German society, which tends to be retrained, which means the culture has a tendency to cynicism
and pessimism (The Hofstede Center, 2015c). A comparison of both, Mexican and German cultural
compass is provided in Figure 7:
Latin America Market Research ………………………………………… 50
Figure 7. Mexico and Germany's Cultural Compass
100
90
80
70
60
50
40
30
20
10
0
97
83
82
81
67
35
69 66
65
40
30
24
Mexico
Germany
Source: adapted from The Hofstede Center (2015c)
General Business Environment
According to the World Bank (2015c) on the Doing Business Report, Mexico has been ranked as the top
39th country among 189 economies on the ease of doing business. Particularly, the country was ranked
in 2014 as the 3rd easiest country to do business in Latin America (World Bank, 2014b). In some
concrete examples, Mexico has made important trade reforms which facilitate the trading environment
in the country, while it has further improved its judicial system to facilitate the enforcing of contracts of
commercial sale disputes (World Bank, 2014b). In the region, Mexico is considered as having the best
performance in terms of the time it takes to enforce contracts (World Bank, 2014b).
On the other hand, Mexico is considered as one of the most open countries to international trade in the
world. The country has signed free trade agreements (FTAs) with 45 nations around the world, including
the European Union. The FTA Mexico-European Union came into force on 1 of July 2000 and through
this FTA, import tariffs are abolished for different goods between the two regions (ProMexico, 2015).
Latin America Market Research ………………………………………… 51
Medical Device Market
Market Value
According to the World Health Organization (2013), the total expenditure on health as a percentage of
GDP in Mexico reached 6.2% and total health expenditure as a percentage of total government
expenditure was 15.4%. While spending is high in comparison to other Latin American countries, it is
important to note that the manufacturing of medical devices in Mexico also plays an important role for
its economy. For the manufacturing market, during 2013 the total value amounted to 15.7 billion USD
and the estimation of the compound annual growth rate (CAGR) for the 2013 – 2020 period is 7.2%
(ProMexico, 2014). However, the manufacturing market is highly driven by non-local multinational
companies through foreign direct investments where medical devices are mainly being exported to the
United States. Among the medical devices which are manufactured in Mexico there are medical,
surgical, dental or veterinary instruments and devices; syringes, needles, catheters; orthopedic articles
and electro diagnostic apparatus (ProMexico, 2014). Production for the local market is relatively low,
thus it is satisfied by imports (ProMexico, 2014). According to ProMexico (2014), regarding the
consumption of medical devices, Mexico is considered as the second largest market in Latin America
following Brazil. As of 2013 total consumption value for medical devices amounted to USD 12.7
billion, and the CAGR in the country has been estimated as 7.0% for the 2013 – 2020 period.
Figure 8 shows sector trade figures for 2013 where nearly half of the medical device trade balance
corresponds to imports. The demanded medical equipment in Mexico includes anesthesia equipment,
electrocardiographs, electro surgery equipment, MRI equipment, X ray equipment, among others.
Latin America Market Research ………………………………………… 52
Figure 8: Mexico's International Trade of Medical Devices 2005 - 2013 (Million USD)
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
2005
2006
2007
Exports
2008
2009
Imports
2010
2011
2012
2013
Trade Balance
Source: adapted from ProMexico (2014)
Market Size – Hospitals
As of 2013 the total number of hospitals that belong to the public sector in Mexico comprehend 22,228.
Of this total, 94% (20,892) are outpatient hospitals and only 6% (1,336) provide hospitalization
services. In terms of hospital beds, the public sector counts with 87,509 hospital beds.
The private sector counts with 3,110 hospitals with a total capacity of 44,115 hospital beds. The
majority of the private hospitals are considered small scale maternity hospitals. It is estimated that
around 77% of private sector hospitals that provide hospitalization services have less than 14 hospital
beds, 12% have 15 to 24 beds, 6% have more than 25 beds and only 5% have more than 50 beds
(Secretaría de Salud, 2015). In addition, total hospital beds per 1,000 population has been reported as
1.5 (CIA World Factbook, 2015c).
Table 8 provides a summary of the market size in terms of hospitals
Table 10: Market Size – Hospitals
Number of
Hospitals in the
Public Sector
Number of
Hospital Beds in
Public Sector
22.228
87.509
Number of
Hospitals in the
Private Sector
Number of
Hospital Beds in
Private Sector
3.110
44.115
Source: CIA World Factbook, 2015c
Hospital Beds
per 1,000
inhabitants
1,5
Latin America Market Research …………………………………………
7
Nature of Demand for the Company’s Products
Predominant medical services provided in Mexico include pathological anatomy, clinical laboratories,
radiology, mammography, magnetic resonance, tomography, ultrasound, and physiotherapy treatment
services. As of 2013, the total number of physiotherapy sessions provided by the public sector totaled
approximately 23.1 million sessions for approximately 2.9 million recovered patients (Secretaría de
Salud, 2013)
According to the Instituto Nacional de Estadística y Geografía (2010), there are approximately 5.74
million people who have declared to have difficulty to do at least one of the following activities:
walking, moving, seeing, listening, taking showers or eating, paying attention or learning. In other
words, they have a type of physical or mental disability. These 5 million people represent 5.1% of the
total population in the country. According to the same source, the most frequently physical disability
found on a national level is related to mobility. 58% of the surveyed population, that is, approx. 3.31
million declared to have limitations for walking or moving (Instituto Nacional de Estadística y
Geografía, 2010).
In this same census, physical disability in Mexico has been reported to be closely related to the aging
population. According to the projections of the National Population Council (CONAPO), the percentage
of seniors (60 and over) in the country's population will grow from 10-15 % and even 25 % in the next
three or four decades, thus, the number of people with disabilities is expected to increase along. With an
aging population on the rise, for Mexico this represents a great social challenge which needs to be
tackled for the next decades. On the other hand, for companies like Biofeedback Motor Control, such
statistical data is of particular relevance, as this is a direct factor that will influence market demand for
the company’s products in Mexico.
Regulatory Environment
The regulatory entity for Medical Devices in Mexico is the Secretariat of Health and the General Health
Law, available at http://www.salud.gob.mx/unidades/cdi/legis/lgs/index-indice.htm. This law is the one
that applies for any regulation regarding medical devices. Within the Secretariat of Health, there is the
Committee for Protection from Sanitary Risks (COFEPRIS) which is the one in charge of registering the
medical devices in Mexico. In addition, the COFEPRIS is issuing the regulation for medical device
imports and exports (International Trade Administration, 2011).
Latin America Market Research ………………………………………… 57
The General Health Law defines medical devices as the appliances, accessories and instrumentation for
specific use intended for medical care, surgical or examination procedures, diagnosis, treatment and
rehabilitation of patients as well as those to perform biomedical research activities (Secretaría de Salud,
2007). In addition, according to this law, the medical devices are classified in three types, being Class I
the one relevant for the company. Class I devices are defined as those that “are very well known in the
medical field, with proven effectiveness and safety, and that generally are not introduced into the human
body”. Class II and Class III devices correspond to medical devices that are introduced to the human
body (International Trade Administration, 2011).
The regulation states that all medical devices in Mexico, must have a sanitary registration and sanitary
authorization. This registration is done by COFEPRIS and it starts with an application and a registration
fee. According to the International Trade Administration (2011), the following documents are required
to register the medical devices:
●
A scientific and technical information describing the characteristics of the device and
demonstration of its safety and efficacy
●
A copy of the label, in Spanish, with information as required by Official Mexican Norms
●
Instructions for the device’s use or operation manual, in Spanish
●
Description of manufacturing process
●
For medical equipment, a description of the product’s structure, materials, parts, and functions
●
Certificate of Good Manufacturing Practices (GMP)
●
Laboratory test results verifying the product’s specifications
●
Bibliographic references
●
In the case of medical devices that use radiation sources, a copy of the license issued by the
Mexican Energy Secretariat (National Nuclear Safety Commission)
In addition to the above documents, user instructions must be provided for those medical devices that
need explicit use instructions. At the same time, operation manuals must be provided for medical
equipment that require in-depth instructions for use or operation (International Trade Administration,
2011).
When the manufacturer of the medical device is different from the one registering the medical device,
an agreement and contract signed by both parties must be presented. The registration of a medical
device lasts 5 years and it can be renewed. For Class I medical devices registration, COFEPRIS is
Latin America Market Research ………………………………………… 58
responsible of replying within 30 days. Lastly, the registration of the medical device belongs to the
manufacturer, not the distributor, which presents an advantage, since the manufacturer has the option of
changing the distributor in Mexico.
In addition, if the medical device is imported, COFEPRIS requires additional documentation for
registration:
●
Certificate of Free Sale (or Certificate for Foreign Government) issued by the authority of the
country of origin, translated into Spanish.
●
Administration (FDA), and assures the authorities of the importing country that the product
complies with U.S. law.
●
Certificate of Good Manufacturing Practice in force issued by the health authority country of
origin or equivalent document issued by the body authorized by the country of origin, translated
into Spanish.
●
Original or certified copy of the original letter of representation issued by the manufacturer, if
the product is not manufactured by the parent company, subsidiary or affiliate of the registrant
in Mexico, authenticated that the legal procedure that exists in the country of origin, translated
into Spanish (International Trade Administration, 2011).
Detailed regulation information for medical devices in Mexico can be accessed in the COFEPRIS
website: Cofepris Imp, Copefris Dispositivos Medicos
Market Entry
As recommended by the International Trade Administration (2011), the first step for manufactures of
medical devices that want to introduce their products to the Mexican market should be to appoint a local
representative. Such representative must be familiar with the import documents and able to apply to the
necessary import documentation (International Trade Administration, 2011). The local representative
can be a distributor or only a representative.
In terms of location, according to the Instituto Nacional de Estadística y Geografía (2010), the regions in
the national territory which possess the most number of inhabitants with disability or a certain mobility
challenge include Zacatecas and Yucatan with 424 and 398 people per every 10,000 inhabitants
respectively. However, although the most population with disability is located in these two states they
only represent 1.3% and 1.7% of Mexico’s total population respectively. In this regard, the state of
Latin America Market Research ………………………………………… 59
Mexico is recommendable to start with a market entry strategy given that it is the most populated state
in the country and in terms of people with disability, the state has 261 people per every 10,000
inhabitants (Instituto Nacional de Estadística y Geografía, 2010). Thus, it is expected that a large
concentration of hospitals or clinics with rehabilitation facilities are located in the state of Mexico.
Potential Distributors
As already mentioned, the best way to enter the Mexican medical device market is through appointing a
reference company or distributor. In this sense, the following distributors are provided:
1. Equipos Interferenciales de México, S.A. de C.V: located in Cuernavaca, and with several
branches around the country, this company specializes in distributing high technological and
internationally certified devices for clinical rehabilitation, research in the areas of rehabilitation
medicine, physical therapy, neurology, sports medicine and occupational medicine. In addition
to the distribution, the company has qualified personnel which are trained to operate complex
technological devices.
Website: http://www.interferenciales.com.mx/index.php
2. TENS S.A. de C.V.: the company sells to both the private and public sector and provides a wide
range of medical devices, including medical equipment for rehabilitation, physical therapy and
sports medicine among other disciplines. The company’s products are recommended by
AMETD, the Mexican Association for Research and Treatment of Pain.
Website: http://www.tensmexico.com/home.php.
General Information for Importers
As previously mentioned, the FTA between Mexico and the European Union entered into force since
July 1, 2000. In this regard, for the products exported to Mexico under the tariff code 95069110 –
Exercising apparatus with adjustable resistance mechanism, there is no import tariff to be paid.
In terms of import operations however, in Mexico there are needed only 4 documents to import. These
documents are:
●
Bill of Lading,
●
Commercial Invoice,
Latin America Market Research ………………………………………… 60
●
Customs import declaration
●
Packing list
In addition, the time to import to Mexico takes on average 11 days, which is below the regional average
of 19 days (Emergo Group, 2015). Compared to other countries such as Brazil (12 days) and Argentina
(30 days), the time to import is relatively fast (Emergo Group, 2015).
Competitors
The main suppliers of medical devices in Mexico are headquartered in Europe or United States,
however regional offices are present in Mexico. These have their own manufacturing facilities to
produce, sell or distribute medical devices. Some of the main players include Johnson & Johnson
Medical Devices, Diagnostics Segment, General Electric Healthcare, Siemens Healthcare, Medtronic,
Baxter International, Philips Healthcare, Abboott Laboratories, Covidien, Cardinal Health and Stryker.
These companies manufacture a wide range of medical devices, including orthopedic devices
(ProMexico, 2015)
In 2012, 723 exporting companies were registered that export medical devices. These companies are
mainly located in Baja California, Chihuahua, Coahuila, Distrito Federal, Estado de Mexico, Jalisco,
Morelos, Nuevo Leon, Sonora and Tamaulipas as seen in the following figure:
Latin America Market Research ………………………………………… 61
Figure 9 . Medical Device Exporters
Source: ProMexico (2014)
In addition, there is a cluster of medical device manufacturers in Baja California, which accounts for
36% of medical device exports and where more than 60 companies are the leading exporters of medical
devices (Emergo Group, 2015).
Market Risks
According to the World Economic Forum (2014), the most problematic factors seen by business
executives for doing business in Mexico include corruption factors, tax regulations, inefficient
government bureaucracy, inflation, crime and theft. Corruption is the most problematic factor when
doing business in Mexico. According to Transparency International (2014) from its Corruption
Perception Index, Mexico scored 34 points which is considered as highly corrupt. Some examples of
corruption issues include unfair competition in government tendering, unjust enrichment, extortion,
abuse of office, among others (Overseas Business Risk, 2015b). In addition, bribery has been reported
as a major issue as well, reaching the police, the judiciary system, registration offices, etc. Lastly,
Latin America Market Research ………………………………………… 62
organized crime and drug trafficking are major issues in the country. The government of President Peña
Nieto has tried to tackle down the drug trafficking aggressively according to Overseas Business Risk
(2015b). Thusm, specific advice is recommendable to look for when wanting to engage in a business
relationship with Mexicans.
Further Recommendations
In order to get to know firsthand the medical device market in Mexico, it is recommendable to assist to
sector specific trade fairs and/or medical congresses in Latin America. Particularly in Mexico, the
following
medical
trade
fairs
(http://www.expomed.com.mx/visitantes.asp)
are
a
and
good
Expo
starting
Proveedores
point:
del
ExpoMED
Hospital
(http://www.proveedoresdelhospital.com/home_expo.html). This way potential business partners or
distributors can be reached out. In addition, it is suggested that contact points are made with chambers
of commerce or specialized trade offices such as ProMexico (https://www.promexico.gob.mx/) or the
Mexican embassy in Germany (http://embamex.sre.gob.mx/alemania/). Such offices are a good starting
point to reach valuable contacts.
Latin America Market Research ………………………………………… 63
CONCLUSION
The present market research report was elaborated for the German Biofeedback Motor Control company
with the aim to provide an insight of the Latin American market of medical devices, in particular for the
markets of Chile, Colombia and Mexico.
The Latin American market has traditionally been overlooked by potential European exporters, however
in other industries it has been demonstrated that Latin America has a lot more appeal for European
companies. In particular for the medical device market, the information provided in this report portrays
a forecast of stable growth and steady economic growth, thus opportunities to establish business
relationships are there to take for the interested companies.
Entering the Latin American markets of Chile, Colombia or Mexico through a distributor or local
representative market entry strategy seems as a good opportunity due to their underdeveloped medical
device market which is mainly satisfied through imports.
Nevertheless, in the case of entering any of the mentioned markets, it is very important to consider
cultural business aspects and language barriers when it comes to conduct business relationships.
It is recommended to Biofeedback Motor Control Company to visit the markets before contacting any
potential distributor in order to obtain a grasp of the markets and to explore trade opportunities.
Latin America Market Research ………………………………………… 64
CONTACT INFORMATION
LESLY CASTRO
[email protected]
ZORE MORA
[email protected]
INSTITUTION INFORMATION
International SEPT Program
Universität Leipzig
Ritterstraße. 9-13
04109 Leipzig
Germany
Latin America Market Research ………………………………………… 65
ABBREVIATIONS
BfMC: Biofeedback Motor Control
CAGR: Compound Annual Growth Rate
CENABAST: Central de Abastecimiento del Sistema Nacional de Servicios de Salud
CFG: Certificate to Foreign Government
CFS: Certificate of Free Sale
ELN: National Liberation Army
FARC: Revolutionary Armed Forces of Colombia
FTA: Free Trade Agreements
GDP: Gross Domestic Product
GNI: Gross National Income
LCU: Local Currency Unit
MFN: Most Favored Nation Tariff Rate
OECD: Organisation for Economic Co-operation and Development
PPP: Purchasing Power Parity
Latin America Market Research ………………………………………… 66
REFERENCES
Biofeedback Motor Control (2015). Power Point Presentation.
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Latin America Market Research ………………………………………… 70
ANNEXES
Annex 1. Map of America
Source: CIA World Factbook (2015a)
Latin America Market Research ………………………………………… 71
Annex 2. List of Countries per region
North America:
• Canada
• Mexico
Caribbean:
●
●
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●
●
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●
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●
●
●
●
●
●
●
●
●
●
●
●
●
●
●
Anguilla
Antigua and Barbuda
Aruba
Bahamas
Barbados
Bermuda
British Virgin Islands
Cayman Islands
Cuba
Dominica
Grenada
Guadeloupe
Haiti
Martinique
Montserrat
Netherlands
Antilles
Jamaica
Dominican Republic
Puerto Rico
Saint Kitts and Nevis
Saint Lucia
Saint Vincent and the Grenadines
Trinidad and Tobago
US Virgin Islands
Central America
• Belize
• Costa Rica
• Honduras
• Nicaragua
• El Salvador
• Panama
• Guatemala
South America:
●
●
●
●
●
●
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●
●
●
●
●
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Argentina
Bolivia
Paraguay
Brazil
Uruguay
French Guiana
Guyana
Chile
Colombia
Ecuador
Suriname
Peru
Venezuela
Latin America Market Research ………………………………………… 72
Annex 3. Variables and Weights
Annex 4. Indicators from Doing Business Report
Latin America Market Research ………………………………………… 65
Annex 5. Indicators from World Bank
Annex 6. Industry Indicators
Latin America Market Research ………………………………………… 66
Annex 7. Final Ranking
Annex 8. Map of Chile
Latin America Market Research ………………………………………… 67
Annex 9. Map of Colombia
Annex 10. Map of Mexico
Latin America Market Research ………………………………………… 68
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