MERCOSUL Classification Alignment
BR-unique
Brazil's four-class device classification system originates from MERCOSUL GMC Res. 40/2000, which harmonised device classification across member states. The framework is largely shared with Argentina (ANMAT), Uruguay (MSP), and Paraguay.
Key differences from EU MDR
| Feature | Brazil (ANVISA) | EU (MDR) |
|---|---|---|
| Number of classes | I, II, III, IV | I, IIa, IIb, III |
| Sub-classes | None | Class I: Is, Im, Ir |
| Classification authority | ANVISA (binding via catalogue) | Manufacturer decides |
Indicative mapping from EU MDR
| EU MDR | ANVISA (indicative) |
|---|---|
| Class I | Class I or II |
| Class IIa | Class II or III |
| Class IIb | Class III |
| Class III | Class IV |
Always verify against the ANVISA catalogue and RDC 751/2022 rules.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.