Post-Market Overview & Ongoing Obligations
What post-market obligations apply?
Once a device is on the Brazilian market, the registration holder and other economic operators (manufacturers, importers, distributors, and healthcare facilities) have ongoing obligations. These fall into five main areas:
| Obligation | Regulatory basis | Applies to |
|---|---|---|
| Adverse event reporting (Tecnovigilância) | RDC 753/2022 | Manufacturers, importers, distributors, healthcare facilities |
| Recalls and field safety actions | RDC 753/2022 | Manufacturers and importers |
| Post-market surveillance (PMS) | RDC 751/2022 | Manufacturers and importers |
| GMP maintenance | RDC 752/2022 | Manufacturers |
| AFE and registration renewal | RDC 755/2022 | All registered entities |
NOTIVISA — Brazil's post-market surveillance hub
ANVISA's NOTIVISA system is the central platform for adverse event and technical complaint reporting. All manufacturers, importers, distributors and healthcare facilities must be registered on NOTIVISA.
Changes to registered devices
After registration, any change that affects safety, performance, intended use, or labelling must be managed through a Petição de Alteração — see Post-Registration Changes.
Official resources
Note: Post-market surveillance (PMS) is mandatory for Class III and IV devices. Class II devices may use a simplified PMS approach (plano simplificado de tecnovigilância) submitted with the Cadastro registration, though some Class II devices may still require full PMS depending on risk profile.