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IMDRF Membership & Brazil's Alignment

Brazil joined IMDRF (International Medical Device Regulators Forum) as a full voting member in 2020, following years as an observer. ANVISA actively participates in IMDRF working groups on:

  • UDI (Unique Device Identification)
  • SaMD (Software as a Medical Device) classification and regulation
  • Clinical evidence for medical devices
  • Post-market surveillance
  • Auditing programme for medical device manufacturers

How IMDRF membership affects Brazil​

IMDRF membership has accelerated ANVISA's alignment with international regulatory norms:

  • Classification: Brazil's four-class system (I–IV) maps closely to the IMDRF classification approach
  • SaMD: ANVISA has adopted the IMDRF SaMD N12 classification framework
  • UDI: ANVISA is implementing UDI aligned with IMDRF guidance
  • Clinical evidence: ANVISA's clinical evidence requirements for Class III/IV are converging with IMDRF guidance
  • GCP: ANVISA recognises ICH GCP for clinical investigations

Practical implications for manufacturers​

Regulatory documentation prepared to IMDRF standards (e.g., IMDRF SaMD N12 classification, IMDRF N47 clinical evaluation framework) is generally accepted by ANVISA, reducing duplication between Brazil and other IMDRF markets.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.