MDSAP · Medium · 14 min lesson
Brazil - ANVISA RDC 665/2022, RDC 687/2022 B-GMP certification and registration holder duties
ANVISA RDC 665/2022, RDC 687/2022, RDC 497/2021, RDC 850/2024, RDC 751/2022, RDC 67/2009 and RDC 23/2012, MDSAP Audit Approach chapters 1, 2 and 4
What you will learn
- Map RDC 665/2022 chapters to the tasks.
- Explain B-GMP and MDSAP reports.
- Handle the Brazilian Registration Holder.
Key takeaways
- RDC 665/2022 is the Brazilian GMP map; cite its articles in your procedures.
- B-GMP under RDC 687/2022 can rest on an MDSAP report issued within three years; four year validity under RDC 850/2024.
- The registration holder answers to Anvisa: 72 hours, 10 days and 30 days for adverse events under RDC 67/2009.
- Field actions are notified in 3, 10 or 30 days under RDC 23/2012 article 9.
- An agreement between maker and holder makes the short Brazilian clocks workable.
Free practice question
Veridia plans a B-GMP renewal and holds an MDSAP report issued 3 years and 4 months ago. The next MDSAP audit is planned in 6 months.
What should the team do?
Check article 9 of RDC 687: the report is outside the three year limit, so bring the audit forward or use another route.
Correct. Article 9 requires issue within three years before filing, so an older MDSAP report cannot support the petition.
File anyway because the report is MDSAP.
Not quite. The age limit in article 9 applies to every recognized report, including MDSAP.
File without a report and say it is available on request.
Not quite. Article 8 requires one of the three routes to be supported at filing.
Cancel the registration to avoid the issue.
Not quite. Cancelling registrations is out of proportion and does not solve the renewal need under article 9 of RDC 687.
Key terms
- B-GMP: The Brazilian good manufacturing practice certificate for medical device manufacturers (RDC 687/2022).
- registration holder: The manufacturer or importer responsible for the device in Brazil that holds the Anvisa authorization (RDC 751/2022 article 4).
- technovigilance: Post-market surveillance of adverse events and technical complaints by the holder (RDC 67/2009).
- field action: An action to reduce the risk of an adverse event from a product already on the market (RDC 23/2012).
- RDC: Resolução da Diretoria Colegiada, a binding resolution of the Anvisa board.
- notification and registration: Class I and II devices are notified, class III and IV registered for ten years (RDC 751/2022 articles 6, 7 and 11).
- MDSAP report use: RDC 687/2022 allows recognized audit reports, such as MDSAP, issued within three years, to support the certificate.
Official sources
- RDC 665/2022, Good Manufacturing Practices for medical devices (Anvisa text)
- RDC 687/2022, B-GMP certification criteria for medical devices
- Anvisa, legislation related to GMP certification of medical devices (RDC 665, 687, 497, 850)
- RDC 751/2022, classification, notification and registration of medical devices
- RDC 67/2009, technovigilance rules for registration holders (Ministry of Health legislation library)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.