MERCOSUL Alignment & GMC Resolutions
BR-unique
Brazil is a founding member of MERCOSUL (Mercado Comum do Sul), comprising also Argentina, Uruguay and Paraguay. Medical device regulation is partially harmonised through GMC (Grupo Mercado Comum) Resolutions, though each country maintains its own national authority.
Key MERCOSUL resolutions for medical devices
| Resolution | Topic |
|---|---|
| GMC Res. 40/2000 | Definition and classification of medical devices |
| GMC Res. 72/1998 | IVD definition and classification |
| GMC Res. 33/2006 | GMP harmonisation |
What harmonisation means in practice
- Each country has its own registration system — a Brazilian ANVISA Registro does not automatically confer marketing authorisation in Argentina (ANMAT) or Uruguay (MSP).
- Technical documentation prepared to ANVISA/GMC standards is largely reusable for ANMAT submissions.
- GMP certificates from ANVISA (CBPF) are generally recognised by other MERCOSUL authorities.