Brazil sets up notification pathway for Class I medical devices and IVDs

The Brazilian Health Regulatory Agency (Anvisa) has published its regulation RDC 270/2019. This regulation:

  • establishes a notification pathway for Class I medical devices and in vitro devices (IVDs)
  • allows qualifying low-risk medical devices to avoid undergoing full ANVISA registration
  • will be implemented in May 2019

The effect of the regulation will be to speed up market access for these low-risk devices. A summary of the new regulation by Emergo explains the details of the regulation and some of the ways Anvisa will monitor and enforce the system.

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Published on 8. March 2019 in News