MERCOSUL Regulatory Updates
This page tracks regulatory updates from MERCOSUL that may affect medical device regulation in Brazil.
MERCOSUL regulatory bodies relevant to medical devices
| Body | Role |
|---|---|
| GMC (Grupo Mercado Comum) | Issues binding resolutions harmonising regulations |
| SGT 11 (Subgrupo de Trabalho 11) | Health surveillance — the working group responsible for medical device regulation |
| REREME (Red de Evaluadores de Regulación de Material Médico) | Technical network of MERCOSUL medical device regulators |
Monitoring MERCOSUL updates
MERCOSUL regulatory updates affecting medical devices are typically published:
- On the MERCOSUL official portal at mercosur.int
- By ANVISA via its international relations page
- Through industry associations (ABIMO participates in MERCOSUL regulatory consultations)
Recent MERCOSUL developments (as of May 2026)
- UDI harmonisation discussions: SGT 11 is discussing a harmonised MERCOSUL UDI framework, but implementation timelines are not yet confirmed.
- GMP mutual recognition: Discussions ongoing but no formal mutual recognition agreement yet in place.
- Classification catalogue harmonisation: GMC working group reviewing alignment of national classification catalogues.
Monitor ANVISA's international relations page for official ANVISA communications on MERCOSUL developments.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.