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 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.