Extension of Brazil GMP Certificates to Four Years is Official

By Luiz Levy and Evangeline Loh

Medical device market regulators in Brazil have officially extended validity of Brazilian Good Manufacturing Practice (B-GMP) certificates to four years for manufacturers participating in the Medical Device Single Audit Program (MDSAP).

Background Consultation

Emergo by UL previously covered Brazilian regulator ANVISA’s Public Consultation (Consulta Pública n° 1.208, 16 October 2023), which proposed to extend B-GMP (RDC 665/2022 and RDC 497/2021)  certificates to four years when a medical device manufacturer has an MDSAP certificate.

B-GMP quality management system regulations in Brazil

Manufacturers of Class III and Class IV higher-risk devices must obtain a B-GMP certificate as part of the medical device registration process (Registro) in Brazil.

In general, ANVISA uses a risk-based approach ( RDC 687/2022, Article 8) to assess if the manufacturer would be subject to an on-site inspection or off-site desktop audit (unless B-GMP is submitted for a manufacturer that is participating in MDSAP and has Brazil within its scope).

B-GMP certificates are currently valid for two years, but this has changed with the Resolution just published.

ANVISA and MDSAP

ANVISA is and has been a member of MDSAP since the program’s inception.

For manufacturers with a quality management system (QMS) audited by an Auditing Organization and issued a MDSAP certificate, the on-site inspection requirement is waived.

Resolution 850/2024

ANIVSA published Resolution RDC 850/2024 (20 March 2024) which amends RDC 497/2021, Article 8, and now officially extends the B-GMP certificate from two to four years when a manufacturer has a MDSAP certificate. Of course, the manufacturer must maintain their MDSAP certificate for the duration of the B-GMP certificate.

In addition, if a manufacturer has requested renewal of their B-GMP certificate but not yet received final approval from ANVISA before entry into force of Resolution 850/2024, the manufacturer can still benefit from the four-year B-GMP extension.

This Resolution enters into force on 1 April 2024.

Concluding Remarks

For manufacturers interested in the MDSAP program and marketing or intending to market their devices in Brazil, note that Brazil as a jurisdiction (MDSAP FAQ Version 016 2017-08-22, Questions 49 and 95) has to be within scope of the MDSAP certificate.

This is exciting news as this further enhances the benefits of MDSAP certification and reduces regulatory costs, as B-GMP certificates are now valid for four years.

This is also exciting in the context of a global regulatory perspective, as recently the Ministry of Food and Drug Safety (MFDS) in South Korea shared that a MDSAP certificate would waive the manufacturer’s on-site Korean Good Manufacturing Practice (K-GMP) audit requirement.