Further Signs that ANVISA May Ease Brazilian GMP Requirements
ANVISA, Brazil’s medical device market regulator, has issued a new public consultation (link in Portuguese) proposing eased Brazilian Good Manufacturing Practice (BGMP) requirements for medical device manufacturers submitting their products for registration.
According to the public consultation, ANVISA may allow registrants to submit proof of their BGMP certification requests rather than actual BGMP certificates in order to initiate regulatory review of their market authorization applications. Currently, registrants must complete BGMP certification before applying for ANVISA approvals.
If ANVISA were to establish such an allowance, manufacturers could potentially see shorter registration times in order to sell their devices in Brazil—although firms would still eventually need to obtain BGMP certification to maintain and renew their registrations.
The proposal obviously raises many questions regarding how such a process would work, and how Brazilian market regisration timeframes would be affected. Emergo Group’s Brasilia office will provide further details on these developments as they become available.