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 of 5 years from the date of distribution for non-implantable devices, or for the expected device lifetime plus 2 years for implantable devices, as required under RDC 752/2022. Records must be made available to ANVISA and state VISA on request.