Reporting Timeframes — 7-day & 30-day Rules
BR-unique
ANVISA's reporting timeframes for adverse events are set by RDC 753/2022:
| Event type | Reporting timeframe |
|---|---|
| Death or serious unexpected injury | 7 calendar days from awareness |
| Serious adverse event (expected) | 30 calendar days from awareness |
| Technical complaint with potential for serious harm | 30 calendar days from awareness |
The clock starts from the date the reporter (manufacturer, importer, distributor, or healthcare facility) becomes aware of the event — not from the date of occurrence.
Annual report
In addition to individual event reports, registration holders must submit an annual adverse event summary report to ANVISA summarising all adverse events and technical complaints in the previous year. See Annual Report.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.