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 or permitted in Brazil — use ANVISA registration only |
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.