REGULATORY & QUALITY RESOURCES
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
Metrology, Standardization and Industrial
Quality (INMETRO) published a new
ordinance, INMETRO Ordinance No.
384/2020, outlining requirements for
conformity assessment of medical devices
regulated by the National Health Surveillance
Agency (ANVISA). The ordinance includes
some of the most significant changes to
medical device regulation in the country in
recent years.
Among the changes, the new ordinance
eases inspection and documentation
requirements, making the process less
cumbersome. It went into effect at the end
of 2020 and will be enforced as of December
28th, 2023.
Validity/Expiration of the Certificate
of Conformity
Under the new ordinance, certificates of
conformity for medical devices will no longer
expire. Instead, the certificate will list the
expiration date as undetermined, and will
depend upon on the execution of a
monitoring audit and be updated
when/where applicable. The applicant is
responsible for keeping the INMETRO
certificate current, taking into account any
change made during the product’s lifespan.
Use of the INMETRO Conformity
Identification Seal
The INMETRO Conformity Identification Seal
must be marked or affixed to the product
and/or printed or affixed to the packaging. In
the case of imported products, the seal may
be affixed after entering the country,
provided it complies with ANVISA
regulations/requirements and the applicant
illustrates control of the application of the
Seal in Brazil through written procedures
and/or documentary evidence from the
logistics center verified in the applicant's
audit.
When the area available for the application
of the Conformity Identification Seal is not
sufficient for the use of the smallest seal size
indicated in the ordinance, or in the case of
sterile single-use equipment, application of
the Conformity Identification Seal can be
done on the packaging.
Schedule/Timeline
In valid certificates issued in accordance with
INMETRO Ordinance No. 54/2016,
certification bodies must update their
certification process and certificates to add
references to the new ordinance during their
next annual supervision assessment, as long
as it occurs after the date of December 28th,
2023.
The maintenance of certifications or
recertifications started before April 30, 2017
may still be carried out based on INMETRO
Ordinance No. 350/2010, up to the limit of
the validity of five (5) years of the certificates
issued through April 30, 2018.
The validity of issued certificates may expire
in advance of these dates, if the Organization
of Certification of Product (OCP) or ANVISA
determines that the manufacturer has
modified the product, critically affecting the
safety of the equipment. In such cases, the
original certificate will be canceled, and the
manufacturer is required to adapt the
equipment to the requirements of the
ordinance now approved for a new
certification.
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 and to have
as reference current technical standards.
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
With the new ordinance, audits will be
simplified and possibly reduced. For
example, the Quality Management System
audit can now be customized and reduced
by making replacements. Audits on the
production line, Product History Record
(RHP), Product Master Record (RMP) and
routine tests can be performed.
If the company seeking certification is not
currently manufacturing the product, an
audit can be conducted based on an analysis
of the procedures and records from the
manufacturing process.
An audit of the Risk Management System at
the manufacturer is mandatory; however,
some audits can be performed outside the
factory. The OCP must justify this action in
the planning of the audit. The audit plan
should include the search for evidence of
aspects of risk management for preliminary
analysis of the Risk Management System.
Documents and records of compliance
needed to meet the necessary requirements
and verified at the factory must be obtained
and analyzed during the audit process.
Intertek Solutions
As a leader in medical device testing and About Intertek
an experienced INMETRO partner, Intertek Intertek is a leading Total Quality Assurance
can offer its Total Quality Assurance provider to industries worldwide. Our
solutions for compliance to the INMETRO network of more than 1,000 laboratories and
offices and in more than 100 countries
ordinance, including:
delivers innovative and bespoke Assurance,
• Testing to applicable safety standards Testing, Inspection and Certification
and regulatory requirements solutions for our customers’ operations and
• Certification services to illustrate supply chains. Intertek Total Quality
compliance Assurance expertise, delivered consistently
• Auditing solutions, including planning with precision, pace and passion, enabling
and inspections our customers to power ahead safely.
• Document review
The Intertek Advantage
For more than 50 years Intertek has been
partnering with medical device
manufacturers to get products to market as
efficiently, and quickly, as possible. With a
full suite of Assurance, Testing, Inspection
and Certification solutions, Intertek provides
Total Quality Assurance throughout the FOR MORE INFORMATION
medical device life cycle.
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Medical INMETRO April 2023