Distribution Records & Traceability

Registration holders and distributors must maintain distribution records that allow tracing of devices from the manufacturer or importer to the final user or point of care. Distribution records must include:

Device name, model, and ANVISA registration number;
Lot/batch number and expiry date;
Quantity distributed;
Name and address of the recipient (healthcare facility, distributor, retailer); and
Date of distribution.

Distribution records must be retained for a minimum period specified by ANVISA (typically 5 years for non-implantable devices, 10 years for implantable devices). Records must be made available to ANVISA and state VISA on request.