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:" (Portuguese for "Batch:") or the internationally recognized batch symbol. For imported devices, both Portuguese and manufacturer labeling must comply with the registered device specifications.

These markings enable ANVISA, healthcare facilities, and distributors to rapidly trace devices involved in adverse events or recalls back to specific production batches, manufacturing dates, and distribution chains for targeted recall actions.

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Official sources

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