New Brazilian Medical Device Regulations in Effect

New rules covering a wide range of medical device and IVD regulations in Brazil have gone into effect as of October 26, 2015.

As Emergo previously reported, the new ANVISA regulations include RDC 36/2015 and RDC 40/2015 covering cadastro and registro device registrations, and also IN 03/2015 pertaining to IVD families.

New requirements for Brazil Registration Holders (BRH) are also in effect; BRHs must now compile and maintain technical dossiers for all Class I and II devices registered with ANVISA.

A 60-day transition period followed ANVISA’s announcement of the new rules in August 2015.

To learn more about medical device and IVD registration requirements in Brazil, we offer the following resources:

• Brazil regulatory process chart
• Video overview of device registration in Brazil
• Whitepaper on Brazil Good Manufacturing Practice (BGMP) quality system requirements