Brazil medical device registration timeline

ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.

Eligibility: Class III and IV primary registration petitions only, medical devices and IVDs (Art. 2), Prior authorisation by one of the four recognised AREE: TGA via the ARTG, Health Canada via a Medical Device Licence, US FDA via 510(k), PMA or De Novo, or Japan MHLW via Shonin (Art. 6), The device must be essentially identical to the one the AREE authorised, down to composition, indications, manufacturer and manufacturing process (Art. 5 II), Excluded if the AREE itself granted the authorisation through an abbreviated route similar to ANVISA optimized analysis (Art. 4), Filed as a secondary aditamento petition; omit it and the registration is analysed by the ordinary route (Art. 11), ANVISA keeps the right to revert to ordinary analysis with reasons (Art. 9) and to decide differently from the AREE (Art. 13)

RDC 497/2021 Art. 8 gives a Brazilian GMP certificate two years. RDC 850/2024 added a first paragraph doubling that to four years where the certificate was granted through MDSAP, conditional on the manufacturer staying in MDSAP for the whole certificate period.

Eligibility: Manufacturer participates in MDSAP, Participation maintained throughout the validity of the certificate