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.

ANVISA medical device and IVD regulatory changes in effect for 2015As 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

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