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.
Official resources
What harmonisation means in practice
Exporting to MERCOSUL neighbours: A Brazilian AFE/registration does not automatically permit marketing in Argentina, Uruguay, or Paraguay. However, technical dossiers and GMP documentation prepared for ANVISA can typically be adapted for submission to ANMAT (Argentina), MSP (Uruguay), or MSPBS (Paraguay). A Free Sale Certificate (Certificado de Exportação) from ANVISA may be required by importing countries as proof of legal marketing in Brazil.