ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022

[liuyy]

RESOLUÇÃO RDC Nº 665, DE 30 DE MARÇO DE 2022
Dispõe sobre as Boas Práticas de Fabricação de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro.
ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022

 

[Mrs Dean]

RESOLUÇÃO RDC Nº 665, DE 30 DE MARÇO DE 2022
Dispõe sobre as Boas Práticas de Fabricação de Produtos Médicos e Produtos para Diagnóstico de Uso In Vitro.
ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022

Hi there!
Good day.

We are a Class III medical device manufacturer in Malaysia, and would like to market our products in Brazil. We have our ISO 13485 certificate ready but do we still need to apply for BGMP? It's a bit confusing here.

Hope you can help us, thanks!

 

[kys123]

Hi there!
Good day.

We are a Class III medical device manufacturer in Malaysia, and would like to market our products in Brazil. We have our ISO 13485 certificate ready but do we still need to apply for BGMP? It's a bit confusing here.

Hope you can help us, thanks!

Yes, you will still need an authorized importer here in Brazil to apply for the BGMP for you.

Another very cool fact is that the BGMP is only valid for that importer, so if another company wishes to market your products, they will also have to apply and pay for the BGMP certificate (15k-ish USD today).

Unless you choose use a company that offers a registration hosting service and allows other companies to use their Anvisa registrations.