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ANVISA Changing Brazilian Market Pathway for Low-risk Medical Devices

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EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA plans to replace the cadastro registration route for Class I medical devices with a notification pathway based on IMDRF recommendations.
  • Stakeholders will have 60 days to submit comments on the proposed change once ANVISA publishes its official public consultation.

Brazil ANVISA changing cadastro registration to notification pathway for low-risk medical devices 2018Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations.

According to Emergo consultants in São Paulo, Brazil’s medical device market regulator ANVISA will issue a 60-day consultation for a proposal to change the agency’s cadastro registration pathway for Class I devices to a notification pathway, with implications for premarket review requirements for affected manufacturers.

Current ANVISA cadastro registration requirements

Under ANVISA’s existing requirements for cadastro registration, lower-risk device manufacturers must submit applications and legal documentation to the regulator for premarket review, as well as provide their Brazil Registration Holders (BRH) with technical dossiers, label and indications for use documentation in case of ANVISA audits.

Once ANVISA publishes its public consultation on the proposed notification pathway for low-risk devices, Emergo consultants will provide further analysis regarding changes to premarket submission requirements.

Additional Brazilian medical device regulatory support:

 

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