The Brazilian Health Authority, ANVISA, has implemented a new Medical Devices Regulation (the “New Regulation”) as of March 1, 2023.
The New Regulation emphasizes the concepts of product safety and quality, and introduces the following changes:
- Reassessment and requalification of device risks based on technology advances
- non-appealable rejection of faulty filings, including those aimed at securing marketing authorization
- phasing-out and market withdrawal rules for devices
- updating the definition of medical devices by incorporating rules for Software as Medical Device (SaMD) solutions and nanotechnology-based materials
- streamlining labelling and use instructions for devices
To learn more about the new regulatory framework and its application please refer to the following website.
