MERCOSUL Harmonised Resolutions
MERCOSUL medical device regulations are issued as GMC Resolutions (Resoluções GMC — Grupo Mercado Comum Resolutions) and are binding on all MERCOSUL member states (Brazil, Argentina, Uruguay, Paraguay). Brazil incorporates these into national law via ANVISA regulations.
Key GMC Resolutions for medical devices:
| Resolution | Topic |
|---|---|
| GMC Res. 40/2000 | Definition, classification, registration and labelling of medical devices |
| GMC Res. 72/1998 | In vitro diagnostic devices — definition, classification, registration |
| GMC Res. 33/2006 | Good Manufacturing Practices harmonisation |
| GMC Res. 12/2014 | Post-market surveillance (Tecnovigilância) harmonisation |
While MERCOSUL resolutions harmonise the regulatory framework, each member state has its own national registration system. A Brazilian ANVISA Registro does not automatically provide market access in Argentina (ANMAT) or Uruguay (MSP).
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.