EMERGO SUMMARY OF KEY POINTS:

• Brazil’s ANVISA has published a new regulation to clarify changes to its Brazil GMP inspection and certification process.
• The regulation, RDC 183/2017, explains which documents are required for BGMP certification as well as which types of establishments that must obtain BGMP certification in Brazil.
• Applicants that submitted inspection requests before the new BGMP certification process was announced will have 60 days to file amendments to ANVISA to qualify for the new approach.

Brazilian medical device regulator ANVISA has shed more light on its planned overhaul of Brazilian Good Manufacturing Practice (BGMP) inspection requirements.

Following ANVISA’s recent publication of RDC 179/2017 establishing a risk-based BGMP inspection approach as well as BGMP certification via desktop for qualifying medical device registrants, the regulator has now issued a new regulation, RDC 183/2017 (link in Portuguese), that establishes the inspection program and administrative procedures for granting GMP certificates for foreign establishments . The new rules detail the issues such as:

• BGMP risk-based inspection approach rules
• List of establishments requiring BGMP certification for commercialization
• Documents registrants must submit to undergo BGMP inspection and certification
• Transition rules and policies for moving to the new BGMP inspection system

“The new inspection rules approved and detailed under RDC 183/2017 give more clarification to ANVISA’s new inspection requirements and will certainly help to expedite BGMP certifications,” says Luiz Levy, Director of RA/QA at Emergo in Brazil. “In addition, ANVISA’s change that reduces its BGMP inspection scope based on risk analysis was a great change that will allow inspectors to focus on critical areas like production, process validation, and design controls and design changes.”

Required documents for BGMP inspections

RDC 183/2017 specifies documentation required for Class III and IV devices in order to qualify for BGMP certification via desktop review. These documents should include:

• Results of quality system inspections or audits conducted within the previous three years
• Declaration that indicates in which countries the products subject to exportation to Brazil are registered
• Copy of a Good Manufacturing Practice inspection or audit report issued by the regulator overseeing the manufacturer’s country of origin, or by an auditing organization accredited by ANVISA
• Copy of an INMETRO certificate for applicable devices

The regulation clarifies that BGMP certification is required for three types of manufacturing facilities. These include facilities that produce final products; facilities that perform final releases of devices in at least one of their production stages excluding design, distribution, sterilization or packaging and labeling; and facilities that produce software as a medical device (SaMD).

Criteria for BGMP certification

ANVISA may issue BGMP certification based on various criteria, according to RDC 183/2017. These include:

• Quality system audit reports from an auditing organization accredited under the Medical Device Single Audit Program (MDSAP)
• Confidential audit information shared based on agreements between ANVISA and other medical device market regulators
• Analysis of previous audit reports issued by members of the International Medical Device Regulators Forum (IMDRF)—Europe, the US, Australia, China, Japan, Russia and Singapore

Third-party quality system audit reports submitted to ANVISA for desktop certification review should be two years old at most, and should include information on device risk classifications, production lines and evidence supporting compliance to BGMP requirements. Furthermore, at this moment ANVISA will only accept audit reports from organizations accredited under MDSAP.

What about firms that already submitted BGMP inspection requests?

A key question that arose following ANVISA’s plan for BGMP desktop reviews for qualifying Class III and IV device manufacturers was how firms that had submitted BGMP inspection and certification requests prior to the desktop review announcement might qualify for the new certification option.

 “For companies that have already submitted BGMP inspection requests but are still waiting for their inspections to occur, ANVISA will require them to submit an amendment within 60 days in order to qualify for the new risk-based inspection approach,” explains Levy.

Additional Brazilian regulatory information from Emergo:

• ANVISA registration consulting for medical device companies
• BGMP implementation and compliance support
• MDSAP on-site training for medical device companies
• Whitepaper: BGMP requirements
• Video overview: Brazil’s medical device approval process