BR
RDC 751/2022 brought Brazil much closer to the international rule set, which makes classification tractable — and leaves registration as the hard part.
Brazil's classification rules were substantially aligned with international practice by RDC 751/2022, so the cascade behaves in ways a European regulatory professional will recognise. That alignment is genuine and it is the good news. The difficulty in this market sits elsewhere: registration with ANVISA is documentation-heavy, requires a local registration holder, and the route depends on the class — the lower two classes are notified, the upper two registered, with materially different timelines. Getting the class right early therefore changes the project plan more than it changes the technical file.
Four classes, I to IV, on the international pattern rather than the European one. As with Canada, the shared Roman numerals invite a mapping that does not hold: the Brazilian scale has an extra step relative to the EU labels, and the boundary between notification and registration falls between II and III with no European counterpart.
NOTE —
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | Low | Notification |
| II | Medium-low | Notification |
| III | Medium-high | Registration |
| IV | High | Registration |
Under RDC 751/2022, in four classes from I to IV. The rules were aligned much more closely with the international rule set than the framework they replaced.
Whether the device is notified or registered with ANVISA, and how much documentation that requires. Classes I and II are notified; Classes III and IV are registered, with longer timelines.
A local registration holder is required. This is independent of the device's class and applies to manufacturers outside Brazil.
The questionnaire classifies under the EU MDR and reports the Brazil class alongside it, with the rules that produced each. Tick this market when you start.
