INMETRO ORDINANCE 384/2020

FOR MEDICAL DEVICES

REQUIREMENTS FOR REGULATED MEDICAL ELECTRICAL EQUIPMENT

A new ordinance in
Brazil brings significant
changes to the process of
auditing and certifying
medical electrical
equipment in devices in the
country. Intertek is
committed to making the
transition smooth and
effective for manufacturers.

In 2020, Brazil’s National Institute of Use of the INMETRO Conformity Schedule/Timeline

Metrology, Standardization and Industrial Identification Seal In valid certificates issued in accordance with
Quality (INMETRO) published a new INMETRO Ordinance No. 54/2016,
ordinance, INMETRO Ordinance No. The INMETRO Conformity Identification Seal
must be marked or affixed to the product certification bodies must update their
384/2020, outlining requirements for certification process and certificates to add
conformity assessment of medical devices and/or printed or affixed to the packaging. In
the case of imported products, the seal may references to the new ordinance during their
regulated by the National Health Surveillance next annual supervision assessment, as long
Agency (ANVISA). The ordinance includes be affixed after entering the country,
as it occurs after the date of December 28th,
some of the most significant changes to provided it complies with ANVISA 2023.
medical device regulation in the country in regulations/requirements and the applicant
recent years. illustrates control of the application of the
Seal in Brazil through written procedures The maintenance of certifications or
and/or documentary evidence from the recertifications started before April 30, 2017
Among the changes, the new ordinance may still be carried out based on INMETRO
eases inspection and documentation logistics center verified in the applicant's
Ordinance No. 350/2010, up to the limit of
requirements, making the process less audit.
the validity of five (5) years of the certificates
cumbersome. It went into effect at the end issued through April 30, 2018.
of 2020 and will be enforced as of December When the area available for the application
28th, 2023. of the Conformity Identification Seal is not The validity of issued certificates may expire
sufficient for the use of the smallest seal size in advance of these dates, if the Organization
Validity/Expiration of the Certificate indicated in the ordinance, or in the case of of Certification of Product (OCP) or ANVISA
of Conformity sterile single-use equipment, application of determines that the manufacturer has
the Conformity Identification Seal can be modified the product, critically affecting the
Under the new ordinance, certificates of done on the packaging.
conformity for medical devices will no longer safety of the equipment. In such cases, the
expire. Instead, the certificate will list the original certificate will be canceled, and the
expiration date as undetermined, and will manufacturer is required to adapt the
depend upon on the execution of a equipment to the requirements of the
monitoring audit and be updated ordinance now approved for a new
when/where applicable. The applicant is certification.
responsible for keeping the INMETRO
certificate current, taking into account any
change made during the product’s lifespan.
INMETRO ORDINANCE 384/2020
FOR MEDICAL DEVICES

Acceptance of Test Reports

Under INMETRO Ordinance No. 384/2020,
there is no longer a test report age (valid
date) regarding acceptance of test reports.
However, test reports must represent the
current product manufactured.

Original test reports, along with any

corrections, revisions, or amendments must
be evaluated together, along with any
changes made to the product. If the OCP
identifies critical changes to the product that
have not been evaluated and may impact
the basic safety of the product or its essential
performance, additional testing may be
necessary.

Audits Intertek Solutions

As a leader in medical device testing and
About Intertek
With the new ordinance, audits will be
simplified and possibly reduced. For an experienced INMETRO partner, Intertek Intertek is a leading Total Quality Assurance
example, the Quality Management System can offer its Total Quality Assurance provider to industries worldwide. Our
audit can now be customized and reduced solutions for compliance to the INMETRO network of more than 1,000 laboratories and
by making replacements. Audits on the offices and in more than 100 countries
ordinance, including: delivers innovative and bespoke Assurance,
production line, Product History Record
• Testing to applicable safety standards Testing, Inspection and Certification
(RHP), Product Master Record (RMP) and
and regulatory requirements solutions for our customers’ operations and
routine tests can be performed.
• Certification services to illustrate supply chains. Intertek Total Quality
compliance Assurance expertise, delivered consistently
If the company seeking certification is not • Auditing solutions, including planning with precision, pace and passion, enabling
currently manufacturing the product, an and inspections our customers to power ahead safely.
audit can be conducted based on an analysis • Document review
of the procedures and records from the
manufacturing process.
The Intertek Advantage
An audit of the Risk Management System at For more than 50 years Intertek has been
the manufacturer is mandatory; however, partnering with medical device
some audits can be performed outside the manufacturers to get products to market as
factory. The OCP must justify this action in efficiently, and quickly, as possible. With a
the planning of the audit. The audit plan full suite of Assurance, Testing, Inspection
should include the search for evidence of and Certification solutions, Intertek provides
aspects of risk management for preliminary Total Quality Assurance throughout the
analysis of the Risk Management System. medical device life cycle. FOR MORE INFORMATION

Documents and records of compliance With engineers and technicians at 12 Centers Americas
needed to meet the necessary requirements of Excellence and 23 labs across the world +1 800 WORLDLAB (967 5352)
and verified at the factory must be obtained dedicated to testing medical devices
and analyzed during the audit process. equipped with state-of-the-art equipment, Europe/Spain
Intertek understands the latest technologies +34 902 377 388
and the regulatory requirements products
must meet. Our focus on quality, safety and Asia
sustainability allows Intertek to help +852 2173 8888
customers successfully launch new medical
devices to various global markets, including
Brazil. [email protected]

Intertek.es

Medical INMETRO June 2021