Lot/Serial Number Requirements

All medical devices placed on the Brazilian market must have clearly visible lot/batch numbers (número do lote) on the outer packaging and, where space permits, on the device itself.

Serial numbers (unique per individual unit) are required for:

• Implantable devices (to enable patient-level traceability); and
• Active devices where individual unit tracking is needed for safety monitoring.

Lot/batch numbers and serial numbers must be:

• Permanent and legible;
• Placed in a location that will not be obscured or damaged in normal use; and
• Preceded by the word "Lote:" or the batch symbol.

These markings enable ANVISA and healthcare facilities to trace devices involved in adverse events or recalls back to specific production batches and distribution chains.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.