Implant Records & Patient Traceability
For Class IV implantable medical devices, ANVISA requires that healthcare facilities maintain records linking each implanted device to the patient who received it. This is Brazil's equivalent of the EU MDR "implant card" requirement.
Manufacturer/importer obligations:
Manufacturers and importers of implantable devices must provide healthcare facilities with sufficient information to identify the device — including:
- Device name and model;
- ANVISA registration number;
- Lot/batch number and serial number (if applicable); and
- Manufacturer contact information.
Healthcare facility obligations:
Hospitals and clinics that implant Class IV devices must record this information in the patient's medical record and maintain it for the patient's lifetime (or a minimum period specified by ANVISA — typically 10 years).
This patient-level traceability is essential for effective recall actions and for long-term post-market surveillance of implantable devices.
Verify all information against official ANVISA sources before making regulatory decisions.