Implantable Devices
Most implantable devices are Class IV under RDC 751/2022.
Key technical requirements
| Requirement | Detail |
|---|---|
| Biocompatibility | Full ISO 10993 evaluation for all materials in contact with body tissues |
| Mechanical testing | Fatigue, wear, corrosion resistance |
| Sterility | All implants must be supplied sterile; full sterilisation validation required |
| Shelf life | Real-time and accelerated aging |
| MRI compatibility | Per ISO 10974 or ASTM F2503 |
ANVISA requires that Class IV implantable devices include a mechanism for patient identification and device traceability — equivalent to the EU MDR "implant card."
Post-Market Surveillance (PMS) or Post-Market Clinical Follow-Up (PMCF) plans may be required for Class IV implantable devices depending on the device type and available clinical evidence. ANVISA evaluates this on a case-by-case basis during pre-market review.
Verify all information against official ANVISA sources before making regulatory decisions.
The implant card must contain at minimum: device name, manufacturer, serial number, implantation date, and patient identifier. ANVISA does not prescribe a specific format (physical card, digital, or barcode), but the mechanism must enable device traceability in post-market surveillance and rapid identification in medical emergencies.