Expiry Date & Lot/Batch Number Requirements
All medical devices placed on the Brazilian market must have clearly visible lot/batch numbers (número do lote) and, where applicable, expiry dates (data de validade) on the outer packaging and, where space permits, on the device itself.
| Element | Format required |
|---|---|
| Lot number | Preceded by the word "Lote:" or the lot symbol (∎) |
| Expiry date | Month/year format; preceded by "Válido até:" or the hourglass symbol |
| Manufacturing date | Month/year format where required |
These markings must be:
- Permanent and legible;
- Placed in a location that will not be obscured or damaged in normal use; and
- In a font size that is readable under normal conditions of use.
Devices without legible lot numbers and expiry dates may be subject to interdição (seizure) by state VISA bodies during market surveillance inspections.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.