EMERGO SUMMARY OF KEY POINTS:

• Brazil’s ANVISA plans major changes to BGMP certification requirements for many higher-risk medical devices.
• Class III and IV medical device registrants will undergo “desktop reviews” rather than onsite inspections for BGMP certification.
• ANVISA will also implement a risk-based quality system inspection approach prioritizing higher-risk device manufacturers.

ANVISA, Brazil’s medical device market regulator, has approved proposed changes to its onsite inspection approach for Brazilian Good Manufacturing Practice (BGMP) certifications, potentially speeding up market authorizations for moderate- and high-risk device registrants.

Emergo consultants in Sao Paulo learned in a meeting with ANVISA that the agency has proposed a modification (links in Portuguese) to RDC 39/2013 pertaining to BGMP certification processes; according to the proposal, ANVISA may issue BGMP certification to a Class III or IV device manufacturer based on “desktop reviews” of technical documentation rather than on-site inspections. Furthermore, the regulator does not plan to issue a public consultation on this modification, but will instead directly publish the regulation as early as October 2017.

More comprehensive BGMP application requirements

Higher-risk medical device registrants should anticipate more extensive BGMP application requirements in order to demonstrate quality system compliance without undergoing inspections by ANVISA. According to Emergo consultants, Brazilian regulators will likely request more thorough information regarding such items as types of products registrants manufacture; risk classification of devices; previous quality system audit results and post-market surveillance.

ANVISA desktop reviews

ANVISA officials’ proposal entails conducting desktop reviews using information provided by Brazilian market applicants; for applicants whose submitted information is considered sufficient, ANVISA reviewers will issue BGMP certificates without conducting on-site inspections.

Passing desktop audits will require registrants to update all quality management system documentation in order to comply with RDC 16/2013, as well as provide Good Manufacturing Practice (GMP) certificates obtained in their countries of origin. (ANVISA has not yet explained which types of GMP certificates—ISO 13485 certification or US FDA Establishment Inspection Reports (EIRs), for example—the agency would accept from foreign manufacturers.)

However, ANVISA will retain the authority to conduct on-site inspections regardless of whether a manufacturer has obtained BGMP certification via desktop review if, for instance, adverse events or product recalls happen.

Factors that may disqualify a higher-risk device from ANVISA desktop review

Although ANVISA’s proposal would apply across a broad array of Class III and IV devices, devices deemed too high-risk or novel would still have to undergo on-site inspections in order to satisfy BGMP certification requirements. In addition, any Class III or IV device registrant whose application materials are deemed by ANVISA desktop reviewers to be inadequate to demonstrate compliance to BGMP will also be subject to on-site inspections.

A risk-based BGMP inspection approach

Along with the new desktop review process, ANVISA also plans to overhaul its approach to carrying out on-site inspections to determine BGMP compliance.

The agency will replace its current, chronological inspection process with a risk-based approach whereby factors such as the following will be used to determine when on-site inspections are warranted:

• Manufacturers that produce novel or high-risk devices
• Registrants that submit insufficient or noncompliant information for BGMP-related requests
• Registrants  whose quality system audit reports from other markets show high numbers of nonconformance reports (NCRs)
• Devices for which adverse events or other post-market issues have been reported either in Brazil or other markets

Luiz Levy, Director of RA/QA at Emergo in Brazil, expects ANVISA’s desktop review proposal to expedite BGMP certification for many Class III and IV device registrants. The agency’s new risk-based quality system inspection process should also allow the agency to more effectively allocate inspection and related resources.

“This is a significant change that will accelerate the BGMP certification process once ANVISA starts relying more on desktop reviews and data from registrants’ countries of origin rather than resource-intensive on-site inspections,” says Levy.

“Additionally, by conducting onsite inspections using a risk-based approach, ANVISA can focus their efforts on higher-risk establishments.”

Related Brazilian medical device regulatory information:

• Brazilian ANVISA medical device registration consulting for medical device companies
• Brazilian Good Manufacturing Practice (BGMP) quality system compliance support
• Whitepaper: Brazilian medical device registration requirements
• Whitepaper: Brazil GMP (BGMP) quality management system requirements