Primary Legislation
The legislative framework
Brazilian medical device regulation is built on three key federal laws:
| Legislation | Key provision |
|---|---|
| Lei 6.360/1976 | Foundational health surveillance law — establishes the regime of sanitary control over products including medical devices |
| Lei 9.782/1999 | Creates ANVISA as an independent federal agency; defines its mandate, structure and enforcement powers |
| Lei 6.437/1977 | Establishes the list of health surveillance infractions and penalties (fines, product seizure, facility closure) |
| Lei 13.979/2020 | Emergency health measures — used during the COVID-19 pandemic; created emergency device authorisation mechanisms |
Key provisions of Lei 6.360/1976
Lei 6.360/1976 establishes that medical devices (and other health products) subject to sanitary control may only be manufactured, stored, distributed, imported, exported or sold in Brazil if they comply with all applicable health surveillance requirements. It creates the registration (Registro) requirement and the framework of sanctions for non-compliance.
Key provisions of Lei 9.782/1999
Lei 9.782/1999 creates ANVISA as an autarquia (federal independent agency) under the Ministry of Health, with its own legal status, administrative and financial autonomy, and the following powers:
- Issuing binding regulatory acts (RDCs);
- Granting and revoking product registrations;
- Granting and revoking AFEs;
- Conducting inspections; and
- Applying administrative sanctions.