Saudi FDA Products Classification

Guidance
‫دليل تصنيف المنتجات في الهيئة العامة للغذاء والدواء‬

Version 4.0

Date of publication 21/4/2020

Date of implementation 21/5/2020

1
Saudi FDA Products Classification
Guidance

Version 4.0

Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please review and send your comments and suggestions to

[email protected]

Please visit SFDA’s website at www.sfda.gov.sa for the latest

update

2
 Saudi Food & Drug Authority

Vision and Mission

‫الرؤية والرسالة‬
Vision

To be a leading international science-based regulator to protect and promote

public health.

‫الرؤية‬

‫أن تكون هيئة رائدة عالميا تستند إلى أسس علمية لتعزيز وحماية الصحة العامة‬

Mission

Protecting the community through regulations and effective controls to

ensure the safety of food, drugs, medical devices, cosmetics, pesticides and
feed.

‫الرسالة‬

‫حماية المجتمع من خالل تشريعات ومنظومة رقابية فعالة لضمان سالمة الغذاء والدواء واألجهزة‬
‫الطبية ومنتجات التجميل والمبيدات واألعالف‬

3
 Document Control

Version Author Date Comments

3.0 Products Classification Department 11/04/2019 Final

3.1 Products Classification Department 21/10/2019 Final

4.0 Products Classification Department 21/4/2020 Draft

4
Table of Contents
1. INTRODUCTION ............................................................................................................................... 6
1.1 OBJECTIVES ................................................................................................................................... 6
1.2 BACKGROUND ............................................................................................................................... 6
1.3 SCOPE ............................................................................................................................................ 6
1.4 GENERAL PRINCIPLES .................................................................................................................... 6
1.5 DEFINITIONS .................................................................................................................................. 8
2 FOOD...................................................................................................................................................12
3. DRUG ..................................................................................................................................................13
3.1 HUMAN PHARMACEUTICAL PRODUCT ..........................................................................................13
3.2 BIOLOGICAL MEDICINAL PRODUCTS ............................................................................................14
3.3 VETERINARY DRUGS ....................................................................................................................15
4. HERBAL AND HEALTH PRODUCTS ...........................................................................................15
4.1 HERBAL PRODUCT .........................................................................................................................15
4.2 HEALTH PRODUCT ........................................................................................................................16
5. COSMETIC PRODUCTS ..................................................................................................................18
5. 1 SKIN PRODUCTS ...........................................................................................................................18
5.2 CLASSIFICATION CRITERIA OF COSMETIC PRODUCTS ...................................................................20
6. MEDICAL DEVICE .........................................................................................................................21
6.1 IN-VITRO DIAGNOSTIC MEDICAL DEVICES (IVDS).......................................................................21
6.2 LABORATORY PRODUCTS FOR NON-MEDICAL PURPOSES ..............................................................22
6.3 ACCESSORIES OF IVD MEDICAL DEVICES .....................................................................................23
6.4 CHEMICALS USED WITH/AS MEDICAL DEVICES .............................................................................24
6.5 IN VITRO FERTILIZATION (IVF) AND ASSISTED REPRODUCTION TECHNOLOGIES (ART) PRODUCTS
…………………………………………………………………………………………………...24
6.6 TOPICAL PRODUCTS ......................................................................................................................25
6.7 RADIATION EMITTING DEVICE/PRODUCTS ....................................................................................25
6.8 GENERAL HYGIENE PRODUCTS ......................................................................................................25
6.9 ASSISTIVE/SUPPORTIVE PRODUCTS ...............................................................................................26
6.10 DEVICES/PRODUCTS FOR PERSONAL PROTECTION ........................................................................27
6.11 GENERAL HEALTH PRODUCTS .......................................................................................................27
6. 12 EDUCATIONAL AND RESEARCH USE ONLY (RUO) PRODUCTS/DEVICES .......................................28
6.13 STERILIZATION AND DISINFECTION ...............................................................................................29
6.14 HEALTHCARE FACILITY PRODUCTS AND ADAPTATIONS ................................................................30
6.15 DENTAL DEVICES ..........................................................................................................................31
6.16 DEVICES REGISTERED AS MEDICAL DEVICES WITHOUT AN INTENDED MEDICAL PURPOSE ............32
6.17 OPHTHALMIC PRODUCTS ...............................................................................................................33
6.18 LUBRICANTS, MOISTURIZERS AND GELS .......................................................................................34
6.19 CONTRACEPTION DEVICES .............................................................................................................34
6.20 DEVICES FOR BLOOD AND ORGAN PRODUCTS................................................................................34
6.21 CUPPING DEVICES ........................................................................................................................35
6.22 IRRIGATION SOLUTIONS ................................................................................................................35

4
 6.23 RAW MATERIALS AND COMPONENTS .............................................................................................36
6.24 SPARE PARTS .................................................................................................................................36
7 TOBACCO ..........................................................................................................................................36
8 ANIMAL FEED AND PUBLIC HEALTH PESTICIDES ..............................................................36
8.1 ANIMAL FEED INCLUDES THE FOLLOWING TYPES ..........................................................................36
8.2 PUBLIC HEALTH PESTICIDES ..........................................................................................................37
9 BORDERLINE PRODUCTS .............................................................................................................37
10 COMBINATION PRODUCT ............................................................................................................38

5
1. Introduction
1.1 Objectives
This guidance presents the Saudi Food and Drug Authority’s (SFDA’s) current view
on specific products or a category of products and whether it should be under the
responsibility of Saudi Food and Drug Authority and particularly where the regulation
may be on the borderline between two or more SFDA sectors. However, this guidance
is not all-inclusive. Moreover, it does not provide any information about risk classes of
medical devices.
1.2 Background
The SFDA consists mainly of four sectors: Food, Drug, Medical Devices and
Operations. Each sector is responsible for distinctive products with different regulatory
requirements. Therefore, the SFDA have been receiving a huge number of requests
from the industry since its establishment. Most are relating to whether a product should
be classified as drug, medical device or food. SFDA is also aware that other reasons
behind this guidance include further identification of the subsequent scheme/path
within each sector. Therefore, this guidance document has been issued to help SFDA
stakeholders as well as SFDA staffs to classify products easily with a view to achieving
greater consistency, transparency and quality of classification decisions relating to
these products.
1.3 Scope
This guidance document pertains to a product or category of products that is under the
responsibility of each sector within SFDA regulation.

1.4 General Principles

SFDA will determine the classification of a product mainly on statutory definitions. Other
definitions included in the associated regulated guidelines will also be considered. For
example, a product may be classified as a medical device if it “does not achieve its primary
intended action in or on the human body by pharmacological, immunological or metabolic
means. If the product acts by such means, it will be classified as a drug. On the other hand,
if the product contains a substance that has an ancillary action by assisting the product in
achieving its primary intended actions, the product may be classified as device. However,
this is not always the case. Some products come at the borderline between two definitions

6
(food/drug) or (drug/medical device). These products will be classified on a case-by-case
basis.
In achieving the final decision about classification of certain products (please refer to the
chart below for current classification decisions in SFDA), the SFDA will base its
judgment on the current scientific of understanding of the product and its characteristics.
Moreover, the SFDA believes that global regulatory convergence is critical in achieving
cooperation among regulatory bodies. Therefore, the authority will make its best
endeavor in aligning its regulations with the common international practice and limit
local requirements to where genuinely required or scientifically justified to protect the
public health.

7
 Chart.1: Classification Decisions in SFDA
Human
Pharmaceutical Drug

Biological medicinal
Drug
product

Health Product Vetirenary Drug

Herbal Medicine Medical Devices

IVD

Non-Medical IVD
Products Classification

Chemical for Medical

Use
Medical Device
Distillation Device
Food Product
General Lab Use
Cosmetic Product
HCT/Ps Product
Combination Product
Radiation Device
Borderline Product

Tobacco

Animal Feed &

Pesticide

Non-SFDA

1.5 Definitions
Animal Feed: Any substances, single mixed processed or semi-processed, intended to feed
animals, and used as a raw material or as an ingredient in the preparation of manufacturing
or processing of feed originating from plant, approved animal source, or aquatic source.
Biological medicinal products: Medicinal products derived from a variety of natural
sources or produced by biotechnology methods and other cutting-edge technologies.
They include a wide range of products such as vaccines, blood and blood components,
allergenics, advanced therapy medicinal products (ATMPs), recombinant proteins and
biosimilars.

8
Combination Products:
A product consists of two or more of items subject to different SFDA’s jurisdictions in
terms of regulatory path, marketing and/or manufacturing. It includes:
A) Integrated combination product:
• A product consists of two or more regulated components that are
combined/integrated as a single product.
B) Non-integrated combination product:
• A product consists of two or more separated items that are contained in the
same package. [Co-packaged combination product].
• Any regulated product packaged separately where the labeling information
refers to be used with another specific regulated product where both are
required to achieve the intended purpose of use. [Cross-labeled
combination product].
Cosmetic: Any substance or mixture intended to be placed in contact with the external
parts of the human body (epidermis, hair system, nails, lips and external genital organs)
or with the teeth and the mucous membranes of the oral cavity with a view exclusively or
mainly to cleaning them, perfuming them, changing their appearance, protecting them,
keeping them in good condition or correcting body odors.
Dietary Supplement: Is a product (other than tobacco) that bears or contains a
concentrated sources of nutrients or other substances with a nutritional or physiological
effect intended to supplement the diet by increasing the total dietary intake and is not in a
pharmaceutical dosage form.
Dosage form: The finished formulation of pharmaceutical product, e.g. tablet, capsule,
suspension, solution for injection, suppository.
Drug: A) An article intended for use in the diagnosis, cure mitigation, treatment, or
prevention of disease and which is intended to affect the structure or function of the body
B) Any Pharmaceutical Product manufactured in a pharmaceutical dosage form
and contain one or more of active substance used externally or internally in
treatment of a disease in human or animal, or prevent the disease.

9
Feed material: Any products of vegetable or animal origin, whose principal purpose is to
meet animals’ nutritional needs, in their natural state, fresh or preserved.
Compound feed: Mixture of at least two feed materials, whether or not containing feed
additives, for oral animal feeding.
Feed Additives: components added to animal feed, which may or may not contain
nutritional value, are intentionally added to the feed for technical, sensory, nutritional
purposes and/or favorably improve animal production and performance or to satisfy the
nutritional needs of animals.
Foodstuff: Any substance whether processed, semi-processed or unprocessed, which is
intended for direct human consumption or to be used in manufacturing, preparing or
treating a foodstuff.
Herbal Product: Any finished labeled medicinal products that contain as active
ingredients aerial or underground parts of plants or other plant materials or the
combination of them, whether in crude state or plant preparation that is used to treat or
prevent diseases or ailments or to promote health and healing. Plant materials include
juices, gums, fatty oils and any other substance of this nature.
Health Product: Finished labeled products in pharmaceutical dosage forms, which are
usually low risk ingredients that are intended to restore, correct, modify physiological
functions by exerting pharmacological, immunological or metabolic actions.
Human cells, tissues, or cellular or tissue-bases products (HCT/Ps): it means articles
containing or consisting of human cells or tissues that are intended for implantation,
transplantation, infusion, or transfer into a human recipient. Examples of HCT/Ps
include, but are not limited to, bone, ligament, skin, dura mater, heart valve, and cornea.
In-Vitro Diagnostic medical devices (IVDs): means a medical device, whether used
alone or in combination, intended by the manufacturer for the in-vitro examination of
specimens derived from the human body solely or principally to provide information for
diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators,
control materials, specimen receptacles, software and related instruments or apparatus or
other articles.

10
Medical device: means any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or other similar or related article:
A. Intended by the manufacturer to be used, alone or in combination, for human
beings for one or more of the specific purpose(s) of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for
an injury or handicap,
- Investigation, replacement, modification, or support of the anatomy or
of a physiological process,
- Supporting or sustaining life,
- Control of conception,
- Disinfection of medical devices,
- Providing information for medical or diagnostic purposes by means of
in vitro examination of specimens derived from the human body;

B. Which does not achieve its primary intended action in or on the human body
by pharmacological, immunological or metabolic means, but which may be
assisted in its intended function by such means.
Premix: are mixtures of vitamins, mineral salts, amino acids, enzymes or others, as
defined by the bylaws, intended to be added to feeds or water, often used as a carrier
substance, used in feed manufacturing to enhance sufficiency.
Public Health Pesticides: Any chemical substances, inorganic, organic or natural
product or biological product containing elements of microorganisms used in the control
of pests (including attractive and repellents substances).
Tobacco: A Product obtained from a blend of Nicotiana Tabacum and / or Nicotiana
Rustica species which has been flue – cured, air cured, fire cured or sweltered.
Tobacco Products: Any products consisting wholly or partially of tobacco leaves as raw
material which has been manufactured for the purpose of direct or non-direct smoking or
absorption such as Cigarettes, Almeassel tobacco, Meassel Fruit flavored, cigar, as well
as E-Liquids and Heated Tobacco Products which are used by Electronic Nicotine
Delivery Systems (ENDS).

11
2 Food
The product considered as a food when it falls under the following categories:

2.1. Meat and meat products

2.2. Fish and Shell-Fish Products
2.3. Milk and dairy products
2.4. Processed fruits and vegetables products
2.5. Cereals, Pulses and Nuts and Their Products
2.6. Vegetable fats, Oils and Their Products
2.7. Water and Beverages, which do not contain ingredients with medicinal effect
2.8. Honey and foods that contain bee products such as royal jelly, bee pollen and propolis
2.9. Energy drinks
2.10. Food additives that are intended for food industrial uses
2.11. Food sweeteners
2.12. Infant and baby foods
2.13. Foods for special medical purposes
2.14. Proteins, Carbohydrates and Amino acids products that are used as food supplement,
with exception of amino acids and protein products in pharmaceutical form
2.15. Vitamins and minerals supplements with exception of supplements marketed in
pharmaceutical forms and with concentrations equal or below the upper
concentration limit provided in the General Rules for Products Containing Vitamins
and Minerals
2.16. Lozenges, which do not contain unacceptable claim or any ingredient with medicinal
effect, and the concentration of Menthol must not exceed the maximum value
permitted of 5 mg as single serving size, and to a maximum daily serving of 50 mg
2.17. Collagen products that may contain vitamins and minerals with exception of products
marketed in pharmaceutical forms
2.18. Food products that contain Moringa leaves with exception of products marketed in
pharmaceutical forms
2.19. Novel foods, which do not contain ingredients with medicinal effect
2.20. Prebiotic and Probiotic for industrial use
2.21. Food products which contain fish oil
12
2.22. Fibers products with exception of products marketed in pharmaceutical dosage
forms
2.23 Sports food such as sports drinks, products in powder forms that are intended for
sports people and persons who exercise to achieve specific nutritional or functional
support, with exception of supplements marketed in pharmaceutical dosage forms
2.24 Weight management products with exception of products marketed in
pharmaceutical dosage forms

Note:
• Teats are subject to the regulation and standards which are issued by SASO and
they are not regulated within SFDA.
• Single use teats used in hospital environment on neonate to administer medications
and special nutrition are regulated as Medical Devices.

3. DRUG
3.1 Human Pharmaceutical Product

A product would be considered as a drug if it falls within the above-mentioned definition.

The definition is including the following products:

3.1.1 One or more vitamins and/or minerals with concentrations above the upper
concentration limit of vitamins and minerals. The upper and lower concentrations
limits will be calculated according to the product total daily dose. (Please refer to
the General Rules for Products Containing Vitamins And Minerals)
3.1.2 Products contain any of the following substances:
• Salicylic acid in concentration more than 2%* (please see cosmetic classification
section for cosmetics containing this ingredient)
• Hydroquinone
• Ichthammol and coal tar
• Tretinoin (Retinoic acid) and its salts
• Glucosamine
3.1.3 Eye preparations
3.1.4 Ear saline preparations

13
3.1.5 Peritoneal dialysis solutions
3.1.6 Solution for hemofiltration and haemodiafiltration
3.1.7 Saline and sterile water that are intended for intravenous injection
3.1.8 Parenteral nutrition solution
3.1.9 Injectable drug dosage form
3.1.10 Enema solutions products (rectal solution products)
3.1.11 Therapeutic Radiopharmaceuticals
3.1.12 Medical gases (Oxygen, Helium, Nitrous oxide, Medical air, Carbon dioxide,
Nitric oxide+ Nitrogen, Oxygen+ Nitrous oxide and Helium+ Oxygen)
3.1.13 Anti-lice products containing non-listed chemical ingredients such as malathion,
permethrin, and pyrethrins

3.2 Biological Medicinal Products

The product is considered a biological drug if it falls under the above definition, and it
includes medicinal products derived from a variety of natural sources:

3.2.1 Blood products and blood derivative products

3.2.2 Vaccines
3.2.3 Biotechnology medicines
3.2.4 Immunoglobulins
3.2.5 Biosimilars
3.2.6 Advanced Therapy Medicinal Products (ATMPs) including:
a. Gene therapy medicinal product
b. Cell based medicinal product (includes both somatic cell therapy medicinal
products and tissue engineered products)
c. “Combined ATMP” products contain as an integral part of the product also
a medical device

Note:
• Please refer to Guideline on Classification of Advanced Therapy Medicinal
Products

14
3.3 Veterinary Drugs
3.3.1 Veterinary Medicinal Product
When a substance, part of a substance or a combination of substances associated with a
therapeutic (medicinal) property or pharmacological effect.
3.3.2 Insecticides

Veterinary products, which contain substances that kill insects or external parasites, such
as pyrethrins, pyrethroids or organophosphate compounds.

3.3.3 Shampoos

A shampoo for animals will be considered medicinal if it contains an insecticide or an

ingredient which has a pharmacological effect or is presented as an insecticidal shampoo.

3.3.4 Teat and Udder Products

Products applied internally to teats and udders for the prevention of mastitis.

3.3.5 Herbal Products

Herbal products require a market authorization if they are medicinal by presentation or

function. For example, a product containing pyrethrum, pyrethrins or alkaloids, such as
digoxin from Digitalis sp., would be considered medicinal by function.
3.2.6 Diagnostic Tools (Testing Kits)
Any substance or combination of substances administered to animals with a view to
making a medical diagnosis.

4. Herbal and Health products

4.1 Herbal product

A product would be considered as a medicinal herbal product when it falls within the above
mentioned definition. The definition includes the following products:
• The number of herbs in the oral dosage form products should not exceed five
herbs.
• Homoeopathic preparations are not allowed to be marketed in Saudi Arabia
due to the lack of supporting evidence of its safety and efficacy.

15
4.2 Health product:
A product would be considered as a health product subject for registration when it falls
within the following definition: Finished, labeled product in pharmaceutical dosage form
which may contain one or more of the following ingredients :
4.2.1 Amino acid
4.2.2 Charcoal
4.2.3 Tar
4.2.4 One or more vitamins and/or minerals with concentrations equal or below the upper
concentration limit provided that none of these vitamins and/or minerals are below
the lower concentration limit. The upper and lower concentrations limits will be
calculated according to the product total daily dose. (Please refer to the General
Rules for Products Containing Vitamins And Minerals)
4.2.5 Medicated throat lozenges like resorcinol, Cetylpyridinium and Benzyl Alcohol.
4.2.6 Antiseptic products intended for human use and containing any ingredients of the
following:
• Benzalkonium
• Benzethonium
• Chlorhexidine
• Chloroxylenol
• Methylbenzethonium
• Povidone-iodine
• Hydrogen peroxide (H2O2)
4.2.7 Alcohol hand sanitizers composed of these ingredients:
• Ethanol 60-80%
• Isopropanol 60-70%
4.2.8 A lipid, including an essential fatty acid or phospholipids e.g. omega 3.
4.2.9 Throat lozenges which consist only of volatile oils, ascorbic acid (or its salts) and
at least menthol with no unacceptable claim and at concentration of 5 mg or more.
The concentration of the individual ingredients (menthol, eucalyptus oil and
Ascorbic acid) must not exceed the maximum value as follows:
• Menthol 5-20 mg

16
 • Eucalyptus oil 0.5-15 mg
• Ascorbic acid 100 mg
4.2.10 Natural enzyme products
4.2.11 Oral and nasal saline solution products
4.2.12 Sulfur in concentration higher than 2 %
4.2.13 Electrolyte products other than those used as fluid replacement for athletes.
4.2.14 Probiotics and prebiotics that are marketed as end products
4.2.15 Food Supplements in pharmaceutical dosage forms
4.2.16 Topical products containing organic acids (Alpha-hydroxy acids (AHAs)) in
total concentration of organic acids more than 10%
4.2.17 Skin Care Products containing urea in a concentration greater than the
recommended by the GSO standards for cosmetic products
4.2.18 Aromatic and medicinal herbal oils that contain one or more of oils that are
extracted from medicinal plants that have non nutritional claims and used
internally
4.2.19 Products containing medicinal herbs that are not in its natural form and have
gone through any manufacturing process such as grinding, extraction,
packaging or any other manufacturing process
4.2.20 Insect repellents in direct contact with human skin
4.2.21 Topical patches, creams, ointments and gels containing counter irritant
ingredient as an externally applied substance that causes irritation or mild
inflammation of the skin for the temporary relieve of pain in muscles or joints
by reducing inflammation in deeper adjacent structures

Note 1:
For further details, please refer to the Data Requirements for Herbal & Health Products
Submission.

17
5. Cosmetic Products

The following list is a main category of cosmetic products with examples (but non-
exclusive):

5. 1 Skin Products
5.1.1 Skin care Products
• Face care products other than facemask, Facemask, Eye contour products,
Lip care products, Hand care products, Foot care products, Body care
products, External intimate care products, Chemical exfoliation products,
Mechanical exfoliation products, Skin lightening products
5.1.2 Skin cleansing products
Soap products, Bath / shower products, Make-up remover products, External
Intimate hygiene products, and other skin cleansing products
5.1.3 Body hair removal product
Chemical depilatories, Physical epilation products, other body hair removal
products
5.1.4 Body hair bleach products
5.1.5 Correction of body odor and/or perspiration
Products with antiperspirant activity, Products without antiperspirant activity
5.1.6 Shaving and pre- / after- shaving products
5.1.7 Make-up products
Foundation, Concealer, Other face make-up products, Mascara, Eye shadow, Eye
pencil, Eyeliner, Other eye make-up products, Lip stick, Lipstick sealer, Other lip
make-up products, Body or face paint, including "carneval make-up", Other
make-up products
5.1.8 Perfumes:
Hydroalcoholic perfumes, Non hydroalcoholic perfumes
5.1.9 Sun and self-tanning products
Before and after sun products, Sun protection products, Self-tanning products,
other sun and self-tanning products
5.1.10 Other skin products:

18
A. Hair and Scalp Products
1. Hair and scalp care and cleansing products:
Shampoo, Hair conditioner, Scalp and hair roots care products,
Antidandruff products, Anti-hair loss products, Other hair and scalp
care and cleansing products
2. Hair colouring products:
Oxidative hair colour products, Non-oxidative hair colour products,
Hair bleaching and dye remover products, other hair colouring
products
3. Hair styling products:
Products for temporary hair styling, Permanent wave products, Hair
relaxer / straightener products, other hair styling products
4. Hair sun protection products, other hair and scalp products
B. Nail and cuticle products
1. Nail varnish and remover products:
Nail varnish / Nail make-up, Nail varnish remover, Nail varnish
thinner, Nail bleach, other nail varnish and remover products
2. Nail care products/ products with protection layer for nail
3. Nail glue remover products
4. Other nail and cuticle products:
Cuticle softener, Nail sculpting products, other nail and cuticle
products
C. Oral hygiene products
1. Tooth care products
Toothpaste, Tooth cleansing powder / salt, other tooth care products,
Toothpaste products contain one of the following ingredients in a
concentration as recommended by the GSO standards for cosmetic
products:
• Triclosan
• Chlorhexidine
• Cetylpyridinium

19
 • Cetrimide
2. Mouth wash / breathe spray:
Mouthwash, Breath spray, other mouthwash / breath spray products
3. Tooth whiteners
4. Other oral hygiene products
5.2 Classification criteria of Cosmetic products:
5. 2.1 Site of application and dosage form

The products should be intended to be placed in contact with the external parts of the
human body (epidermis, hair system, nails, lips and external genital organs) or with the
teeth and the mucous membranes of the oral cavity. Products that are intended for
(internal use) cannot be considered to be cosmetic products, e.g.:
• Products that are taken orally (syrup, solution, drink, capsules, tablet…etc)
• Products that are taken through the eyes or nose or ear (drops,
sprayer...etc)
• Products intended for injection (IV, IM, IS…etc)
• Products that are taken through the anal or vagina (Enema, supposotiry,
solution, tab, capsules… etc)
5.2.2 Ingredients
Cosmetic products should not contain any medicinal or therapeutic substances. Also, the
cosmetic products shall comply with the COSMETIC PRODUCTS SAFETY
REQUIREMENTS GSO 1943 and circulars issued by SFDA.
5.2.3 Product main function and claim
The product should be applied to the external parts of human body with a view mainly to
cleaning them, perfuming them, changing their appearance, protecting them, keeping
them in good condition or correcting body odors.
Cosmetic products should not contain medicinal or therapeutic claims, and they should
not have a significant physiological effect.
5.2.4 Product presentation
The product should not be presented as treating or preventing disease in human beings.
The following features of the product should be taken into account:

20
 • Product claims and the context in which the claims are made
• Labeling and packaging/packaging inserts (including graphics)
• Promotional literature, including testimonials and literature issued by third
parties on behalf of the supplier
• Advertisements
• The product form and the way it is to be used e.g. capsule, tablet, injection
etc
Particular target of the marketing information e.g. specific population groups with, or
particularly vulnerable to, specific diseases of adverse conditions.

Note:
All cosmetic products must comply with the following:
• Safety Requirements of Cosmetics and Personal Care Products
GSO1943, in addition to the specific product standard (if any), which
can be obtained through the GSO website: www.GSO.org.sa
• Circulars issued by SFDA
• Any other technical requirements specified by the SFDA

6. Medical Device
The medical device definition states that Medical device “means any instrument,
apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article . . .”. The SFDA’s interpretation is
that “similar or related article” under this definition should mean any article in any form.
However, “similar or related articles” may be classified as devices as long as they also
meet the conditions stipulated in point A and B of the medical device definition.

Note:
• Please refer to MDS-G5 (Guidance on Requirements for Medical
Devices Listing and Marketing Authorization)

6.1 In-Vitro Diagnostic medical devices (IVDs):

Examples:
• Reagents used for clinical diagnostic
• Blood glucose meters and strips
• Blood collection tubes, urine sample containers are considered as IVDs

21
 • General-purpose laboratory equipment labeled or promoted for a specific
medical use
• Densitometry analyzer IVD
• Self-pregnancy test
• The calibrators and control materials used to verify the performance of the
analyzers
Note:
• Lancet and pen are medical devices and could come in the same kit with blood
glucose meter. In this case, the whole kit is considered as IVD.

6.2 Laboratory products for non-medical purposes:

a. Products for General Laboratory Use (GLU) are not considered in vitro diagnostic
medical devices unless such products are intended for clinical diagnostic purposes.
The labeling shall indicate that the device is For General laboratory Use and Not
for use in diagnostic procedures
Example:
• Centrifuge
• Scales
• balances
• Incubators
• Drying oven
• Autoclave for laboratory use
• Multipurpose tubes
• Pipettes
• Mixers
• Shakers
b. Equipment or instrument for detection, reading of non-clinical samples, e.g.
pathological agents in the environment, are not IVDs neither general laboratory use.
Therefore, they are not regulated by the SFDA
c. Devices for detection of agents of biological or chemical warfare in the
environment are not IVD because they do not have a medical purpose
22
 d. Devices for non-medical purposes, even if these devices are used for in-vitro
examination of specimens derived from the human body, for example paternity
tests or tests for detecting drugs of abuse/alcohol, are not IVD’s. therefore, they are
not regulated by the SFDA
e. All kits such as reagents, standards, calibrators indicators …etc, which are used
for non-clinical / non-medical purposes are not considered IVD medical devices.
However, these kits shall obtain a Medical Device Importation License (MDIL) as
non-medical IVD
Examples:
• Reagents used for food and water testing
• Limulus Amebocyte Lysate (LAL) tests for the detection of of
endotoxins in injectable pharmaceuticals, biological products and
medical devices
• Distillation machines used in the medical field / applications only
● International quality and efficiency samples for clinical/medical labs
Note 1:
GLU should not be used for medical purposes. For example, GLU
incubators is not intended to cultivate microorganisms and for the purpose
of diagnosis of disease.

6.3 Accessories of IVD medical devices:

The accessories are treated like IVDs in terms of the applicable regulations. They are
intended specifically by their manufacturer to:
• Be used together with an IVD medical device to enable that device to be
used in accordance with its intended use as an IVD medical device
• Or to augment or extend the capabilities of that device in fulfilment of its
intended use as an IVD medical device
Examples:
• A cleaning solution specifically intended by its manufacturer to be used
with a defined automated IVD instrument
• Bar code scanners
• General media such as saline for running instruments

23
6.4 Chemicals used with/as medical devices:
Some chemical substances and mixtures which are used in its final form in some medical
device application require Medical Device Importation License.
Example:
• Chemical substances and mixtures used in fabrication of prosthesis
• Calibration gases and chemicals for medical devices
• Chemical substances and mixtures used to sterilize medical devices

Note:
Chemicals which fall into the above category shall obtain a Medical Device
Importation License. However, if the definition of a medical device or an
accessory applies, the product must comply with the relevant Medical Device
Interim regulations

6.5 In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART)

products:
Because IVF procedure and product is intended to modify and support a physiological
process, they are considered medical devices under the Medical Device Interim Regulation.
Examples of products, which could be qualified as medical devices:
• IVF workstations
• Pipettes or syringes
• Washing, separating, sperm immobilizing, cryoprotecting solutions
• Devices manufactured utilizing animal tissues or derivatives rendered non-
viable
• Devices incorporating, as an integral part, a human blood derivative or a
medicinal product is liable to act on the human body with action ancillary
to that of the devices
• Media intended for use in the IVF process to support the growth storage of
the embryo

24
6.6 Topical Products:
6.6.1 Wound Management products:
If a wound management product acts physically and does not achieve its primary
intended action in or on the human body by pharmacological, immunological or
metabolic means, it is considered a Medical Device.
Examples of medical devices:
• Non-medicated dressing used as a physical barrier, for compression or for
absorption of exudates such as Hydrogel dressings and Alginate dressing
• Devices principally intended to manage the micro-environment of a wound
such as honey wound dressing gel
• Wound dressing with antimicrobial substance such as silver to protect the
dressing and reduce odor
• Absorbable hemostatic dressings
• Silicone sheets or gel for scars
• Topical patches, creams, ointments and gels that externally applied for the
purpose of temporary relieve of pain and irritations

6.7 Radiation Emitting Device/products:

Any device or component of device or accessory to a device, which produces and emits
radiation for the purpose of diagnosis, treatment or alleviation of disease, an injury is
considered a medical device.
Examples:
• Imaging Products (X-ray, CT, MRI, US, and Nuclear imaging products)
• Diagnostic Radioactive materials
• Digital imaging/x-ray film cassette
Note:
In-vivo dosimeter to record dose received by a patient during a radiotherapy
procedure is a medical device.

6.8 General hygiene products:

General hygiene products are not considered medical devices, as the medical definition
does not apply. Moreover, some of these products may achieve its intended purpose
through chemical action on the human body.

25
 Examples of non-medical devices:
• Baby nappies
• Feminine hygiene products (sanitary pads)
• General hand cleansing wipes
• General use disinfectants / cleaners for environment, rooms, surfaces
• Dental disclosing solution/tablets
• Insect repellent
However, similar products may be regulated as medical devices, if there is a specific
medical purpose.
Examples of medical device:
• Sanitary pads claiming pain relief by physical means
• Nibble shields to protect or relieve sore, damaged or cracked nipples or to
be which is used to cover and protect the nipple of a nursing mother
• Electrical and manual Breast pumps
• Surgical Razors and clippers
• Reusable/ single use Patient Bedding set
• Disinfectants claiming prevention of disease
• Sitz bath
• Anti-lice products containing natural source oils or ingredients
6.9 Assistive/supportive products:
Assistive and products/devices are regulated as medical devices if they are intended for
alleviation of or compensation for an injury or handicap or support of the anatomy of
human beings.
Examples of medical device:
• Wheelchairs
• Patient’s beds
• Hearing aids
• Walking crutches
• Patient hoists
• Commode chairs

26
 • Abdominal/breast/perineal binders
• Orthoses
However, products for daily use by everyone are not to be considered as medical device
Examples of non-medical devices:
• Portable ramps
6.10 Devices/products for Personal protection:
If the product is used in a medical field such as operating room with a view to protect the
health and safety of the patient, it is considered a medical device. Where a product is
intended to protect the user then it falls outside the scope of medical device interim
regulation.
Examples non-medical device:
• Non-medical protective gloves
• Dust Mask
• Gum shields for boxers
• Air Purifying Dust/Particulate Respirators
These types of products should not contain any therapeutic (including preventive) claims.
However, if such claims are present or implied, the product is considered to be medical
device.
Examples for medical devices:
• Surgical and examination gloves
• Surgical and examination Face masks
• Surgical apron
• Sharps containers
• Surgical apparel which includes surgical caps, hoods, masks, gowns,
drapes, operating room shoes and shoe covers, and isolation masks and
gowns
6.11 General health products:
Products for sport or leisure purposes which are used to maintain a healthy status are not
considered to be medical devices unless there is intended medical purpose like treatment
or diagnosis of pain or injury or monitoring of disease.

27
Examples for sport products that are not considered medical devices:
• Fitness equipment in general
• Manual massager with no medical purposes
• Watches/activity trackers with/without a heart rate monitor
Examples of medical devices:
• Heat/cold pads for pain relief
• Bandages
• Electrical nerve stimulator for pain relief
• Body Composition analyzer
• Heating and chilling units for packs
• Devices for rehabilitation

Note:
Blood pressure monitors are considered to be medical devices regardless of where
they are used.
Smartwatch is considered as a medical device when it has diagnosing features.

6. 12 Educational and Research Use Only (RUO) products/devices:

6.12.1 Medical devices for research/educational use:

Medical Products/devices which fall into this category shall obtain a Medical Device
Importation License which are based on a purchasing order and a attestation letter from
the end user.

6.12.2 Kits for research/educational use:

Kits which fall into this category shall obtain a Medical Device Importation License.
6.12.3 Devices labeled as for Research Use Only “RUO”:

RUO devices must have no intended medical purposes and be labeled “For research Use
Only” to avoid their potential misuse by institutions or laboratories. Such devices are not
considered Medical Devices. However, they shall obtain a Medical Device Importation
License. This type of product may target the local market and a purchasing order and an
attestation letter from a buyer is not required.

28
Examples:
• RUO products used for Basic Research in research centers
• RUO products used in Pharmaceutical Research
Note:
All RUO products/devices shall obtain a Medical Device Importation License
(MDIL).

6.12.4 Educational Devices:

Devices for educational and training purposes are not regulated as medical devices:
Examples:
• Mock-ups
• Patient simulators

6.12.5 Demo Medical Devices:

If a device is intended for presentation or demonstration proposes, it shall be labeled “for
presentation or demonstration purposes only”. Medical Device Importation License is
required for this type of devices.

6.13 Sterilization and disinfection:

Classification of disinfectants is based on the intended purpose of the product. Any article
intended to be used for disinfection of medical devices is considered to be a medical device.
A disinfectant is not considered an accessory to the medical device because it is explicitly
stated in the definition of medical device and, therefore, is a standalone medical device.
However, a disinfectant that is specifically intended for the disinfection of a specific
medical device is considered an accessory to this device.
Example of medical devices:
• Ethylene oxide sterilizer
• Detergents for sterilization of medical devices
• Disinfectants for dental water line and the fluid pathways of haemodialysis
machine
• Denture disinfecting products
• Medical Washers

29
Note1:
A pre-sterilization device to clean instruments before being sterilized is
considered a medical device. For example, Ultrasonic cleaning unit.
Note2:
Accessories of medical device disinfectants falls under the scope of Medical
Device interim regulations
Examples of sterilization accessories:
• Sterilization packaging.
• Physical/chemical/enzymatic Sterilization process indicator.
• Instrument tray
• However, general disinfectants intended for general use for rooms, hard
surfaces are not considered medical devices. Claims corresponding to
these devices should be clearly distinguished from those for a medical
device status.

6.14 Healthcare facility products and adaptations:

Not all devices/ equipment, which are used in the health care facility, are medical devices.
As these devices do not meet the medical device definition.
Examples of non- medical devices:
• Medical gas pipeline system (excluding system with pressure gauges and
regulators)
• Medication refrigerators
• Bedside cabinets
• Overbred tables
• Trolleys for general use (Crash/Emergency trolley is a medical device)
• Mayo Stand
• Air purifiers / Air decontamination units / Mobile air decontamination units
• Gallipots
• Drug storage cabinet
• Hospital linen hampers
• Mortuary fridge

30
However, some devices are considered medical
Example of medical devices:
• Examination/treatment chair
• Surgical lights as these devices are used to effectively illuminate the field
or the patient
• Patient’s beds
• Devices intended for temporary storage and transport of organs for
transplantation (i.e. containers, bags and similar products)
• Devices intended for long term storage of biological substances and
tissues such as corneas, sperm, human embryos, etc. (i.e. containers, bags
and similar products)
• Fridges specifically intended for storing blood , tissues etc
• Devices intended to be used for a temporary containment or storage
function, e.g. cups and spoons specifically intended for administering
medicines

6.15 Dental devices:

Dental devices, which used for treatment of patient, are considered Medical Devices.
Examples:
• Toothbrush (Manual and Powered)
• Dental impression materials and (mixer/syringe /trays).
• Dental restorative materials (composites /glass ionomer …)
• Restorations and base metal alloys
• Implant system
• Amalgamator
• Articulator and facebow
• Dental units
• Scaler
• pulp tester
• rubber dam and accessories
• orthodontic appliance and accessories
• Dentistry products with aluminum chloride used in hemostasis.
• A 5% sodium fluoride desensitizing agent which is administered by a dental
professional

31
 • Dental operating light
• Tooth whiteners products containing more than 6% Hydrogen Peroxide
Example of non-medical products:
• Dental casting furnace
• Dental laboratory drilling system hand piece/motor
• Dental laboratory burs
6.16 Devices registered as Medical Devices without an intended medical purpose:
There are some devices which fall under the scope of the Medical Device Interim
Regulation (MDIR). These devices are covered below and shall also be classified using
the classification rules for medical devices.

6.16.1 Contact lenses or other items intended to be introduced into or onto the eye.
• For Example: Non-prescription colored contact lenses
6.16.2 Products intended to be totally or partially introduced into the human body
through surgically invasive means for the purpose of modifying the anatomy or
fixation of body parts with the exception of tattooing products and piercings.
• For Example: Solid body contour modifying implant (e.g. Clavicle or
collarbone piercing)
6.16.3 Substances, combinations of substances, or items intended to be used for facial or
other dermal or mucous membrane filling by subcutaneous, submucous or
intradermal injection or other introduction, excluding those for tattooing.
• For Example: Dermal fillers

Note1:
Except for Hyaluronic acid and botulinum toxin injection. Please refer to SFDA
circular No. 33991

6.16.4 Equipment intended to be used to reduce, remove or destroy adipose tissue, such
as equipment for liposuction, lipolysis or lipoplasty.
• For Example: Body sculpting equipment
6.16.5 High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-
violet) emitting equipment intended for use on the human body, including
coherent and non-coherent sources, monochromatic and broad spectrum, such as

32
 lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair
removal or other skin treatment.
• For Example: Intense pulsed light (IPL) machines for body hair removal
6.16.6 Equipment intended for brain stimulation that apply electrical currents or
magnetic or electromagnetic fields that penetrate the cranium to modify neuronal
activity in the brain.
• For Example: Transcranial (no surgically invasive) stimulation
6.17 Ophthalmic products:
6.17.1 Sunglasses and spectacle frames:

Spectacle lenses which are used to attenuate rays of light by absorption, reflection, or
polarization to protect the eyes from light are considered medical devices.

6.17.2 Eye drops:

Eye drops intended for the alleviation dryness or discomfort caused by environmental
factors are considered medicinal products and regulated by the Drug Sector.

6.17.3 Balanced Salt Solution(BSS)

BSS intended for eye irrigation during surgical procedure is considered a medical device.
see 5.2.1.

6.17.4 Contact lenses and their care products:

Non-corrective lenses, coloured or not are considered to be medical devices.

Examples:
• UV blocking contact lenses to alleviate photophobia
• Contact lenses for therapeutic use as a bandage
Note:
• Contact lenses for cosmetic purposes which have no medical claims must
comply with the Medical Device Interim regulation. See 5.16
• Products specifically intended to be used for disinfecting, cleaning,
rinsing or, hydrating contact lenses are medical devices.

33
6.18 Lubricants, moisturizers and Gels
6.18.1 Sexual Lubricant:
A non-medicated substance intended to be applied to the penis and vagina for lubrication
during sexual intercourse. It is considered a medical device.
6.18.2 Coupling gel:
A medium designed to be applied between an analytical device (e.g., ultrasound
transducer) and the patient, allowing signals to pass through the skin during an
examination. This type of products is considered a medical device
6.18.3 Body orifice gel:
A substance intended to facilitate entry of a device into a body orifice in the body
whether it is a natural opening or any permanent artificial opening. It is considered a
Medical Device.
Example:
• Products containing lactic acid for changing vaginal PH

6.19 Contraception devices:

A contraceptive product which acts as by physical means and is intended to control birth
is considered a medical device.
Examples:
• Condoms with/without spermicide
• Condom with desensitizing agent such as benzocaine
• Contraceptive diaphragms
• Intrauterine device IUD /with Copper
However, if a product has pharmacological, metabolic or immunological actions. Then, the
product is considered medicinal product.
Example of medicinal products:
• Intrauterine device with progestin
6.20 Devices for blood and organ products
• Blood bags (including those containing or coated with an anticoagulant) are
considered to be medical device
• Kidney donor-organ preservation/transport perfusion set is considered a medical
device

34
 • Hemodialysis Solutions
• Organ preservation solutions

Note:
• Minimally manipulation biological products intended for human application
and minimally manipulation biological products (e.g. bone ligaments, tendons,
fascia, cartilage, ocular tissues (corneas and sclera), skin, vascular grafts
(veins and arteries except preserved umbilical cord veins), pericardium,
amniotic membrane (when used alone without added cells for ocular repair),
heart valve allografts), excluding the following:
• Vascularized organs (liver, kidney, lung, heart….etc.)
• Major manipulation (e.g. advanced therapeutic drug, gene therapy,
tissues engineering therapy)
• Biologic products imported for research purposes.

Must obtain a Medical Device Importation License.

6.21 Cupping Devices:

Devices used to perform cupping include suction cups and suction pump are considered
to be medical device.
Examples of Cupping Devices:
• Suction cup
• Suction pump
• Twist rotary
• Rubber bulb suction

Note:
• Please refer to SFDA.MD 0001/2017 (Safe Use and Handling of Cupping
Devices and their Applications)

6.22 Irrigation solutions:

Irrigation solutions intended for mechanical rinsing are considered to be medical devices
unless such solutions contain ingredients that have an antimicrobial action on the body
such as chlorhexidine and iodine. In this case, such products are regulated by the drug
sector.

35
6.23 Raw materials and components:
Raw materials, component parts or semi-finished products that requires further
manufacturing process are not considered medical devices. However, these products shall
obtain a Medical Device Importation License
6.24 Spare parts
Medical device spare parts which are supplied for the replacement of existing components
of a medical device that has already obtained a medical device marketing authorization or
listed in the medical device national registry are not considered medical devices as long
as they do not significantly impact the performance and safety of a medical device. If spare
parts, however, change significantly the characteristics or performances of a device with
regard to its already established conformity, such spare parts are to be considered as devices
in their own right.

7 Tobacco:
It includes the following product types:
1. Cigarettes
2. Cigars and Tuscan cigars
3. Almeassel tobacco
4. Hand-rolling tobacco and A mixture of tobacco pipe
5. E-Liquids and Heated Tobacco Products which are used by Electronic Nicotine
Delivery Systems (ENDS)
Non-smoked tobacco such as (Timpak, shamma, swika etc.) is prohibited.
8 Animal Feed and Public Health Pesticides:
8.1 Animal Feed includes the following types:
1. Feed materials
2. Feed additives
3. Premixture
4. Compound feed

Note:
Please refer to the SFDA Guideline for registration of Feed.

36
8.2 Public Health Pesticides

Note:
Please refer to the SFDA List of Public Health Pesticides.

9 Borderline Products:
Products which are difficult to determine whether they are considered as drugs, medical
device, herbal or health products are called borderline products.
There are different categories of borderline products, and it may fall generally into the
following:
o Food products, especially dietary supplement.
o Cosmetic product
o Health products
o Herbal products
o Drug
o Medical device
The following criteria may be taken into consideration during classification decision-
making process:
o Product ingredients and format
o The claim about the product
o Public perception and history of use
o Products representation to the consumers
o The mode and mechanism of action
o Similar classification decisions in SFDA
o Classification schemes of other regulatory authorities

37
10 Combination product:

Note 1:
Please refer to SFDA Guidance for Combination Products Classification:

https://www.sfda.gov.sa/ar/oper/Documents/GuidanceCombinationProductsClassification.pdf

In order to decide whether a product is regulated as a medical device or a medicinal

product, the following points should be considered:
• The intended purpose of the product taking into account the way the product is presented
• The method by which the intended purpose is achieved.
Products that achieve their intended purpose by pharmacological, immunological or
metabolic action in/on the body; shall be regulated by drug Sector
Products that do not achieve their principal intended action in or on the body by
pharmacological, immunological or metabolic means, but that may be assisted in its
intended function by such means, shall be regulated by medical device sector.
Examples of combination products:
• Pre-filled syringes
• Transdermal patches
• Wound dressing with antimicrobial agent
• Surgical scrub brush with antimicrobial agent
• A Helicobacter pylori breath test kit containing labelled urea
- Urea is considered a medicinal substance
- A sample container is considered an IVD
• First aid kits
Note 2:
For first aid kits, please refer to the Guidance on Criteria of Medical Devices
Bundling/Grouping within one MDMA Application

38
 Appendix 1
What is New in The Guidance for Products classification (version 3.2)?

The following table shows statements that added, deleted or replaced to the
past version 3.2 October 21, 2019:

Section Current Amendment

Modified:
Biological medicinal product
Drug
1.5 Definitions
Added:
Combination product
Human cells, tissues, or cellular or tissue-based products
(HCT/Ps)
2.15 allowed limits of vitamin and minerals are
clarified.
2.16 allowed concentration is clarified
2 Food
Classification note on Teats:
Teats are not subject to SFDA regulation
Added:
3.1 Human Pharmaceutical 3.1.3 Eye preparations.
Drug
3.1.4 Ear saline preparations.
3.2 Biological Medicinal
Examples are added.
products
Modified:
4.2.12 Oral and nasal saline solution products.
4.2.22 Topical patches, creams, ointments and gels
containing counter irritant ingredient as an
4.2 Health Products externally applied substance that causes irritation or
mild inflammation of the skin for the temporary
relieve of pain in muscles or joints by reducing
inflammation in deeper adjacent structures
Clarified:
Topical patches, creams, ointments and gels that
6.6 Topical Products
externally applied for the purpose of temporary relieve of
pain and irritations

39
6.16 Devices register as
Added:
Medical Devices without an
6.16.3 Note
intended medical purpose:
6.23 Raw materials and These products shall obtain a Medical Device
components: Importation License
Added
10 Combination Product
Note 1.

40
 Appendix. 2
‫المالحظات حول دليل تصنيف المنتجات‬
Comments on Products Classification Guidance

[email protected] :‫الرجاء تعبئة هذا النموذج وإرساله عن طريق البريد اإللكتروني‬

Please submit comments to the following E-mail: [email protected]
‫المالحظات المقترحة‬ ‫نص البند‬ ‫رقم البند‬
Proposed Amendment Item text Item No.

9
10

41