Labelling Requirements (RDC 754/2022)
Medical device labelling in Brazil is governed by RDC 754/2022. The label must include:
| Mandatory element | Notes |
|---|---|
| Device name and description | Trade name and generic description |
| ANVISA registration number | Reg. ANVISA number on outer packaging |
| Manufacturer name and address | Full legal name and address |
| Importer name and address | If device is imported |
| Lot/batch number | Lote: followed by the number |
| Manufacturing date | Month/year |
| Expiry date | Month/year (where applicable) |
| Sterilisation method | For sterile devices — "ESTÉRIL" symbol |
| Single-use indicator | "USO ÚNICO" or do-not-reuse symbol |
| Instructions for use reference | For complex devices |
| Storage and transport conditions | Temperature range, humidity, light sensitivity |
| CE marking | NOT required devices must not bear CE marking; number in Brazil — use ANVISA registration only |
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
Footnote: Devices submitted to ANVISA must not bear CE marking on their labels or packaging. If a device is manufactured for multiple markets, separate labelling for the Brazilian market (without CE mark) is required. Presence of CE marking on devices intended for Brazil may result in ANVISA deficiency questions or rejection.