Implantable Devices
Most implantable devices are classified as Class IV (highest risk) under RDC 751/2022, though some simple implantable devices (e.g., bone fixation plates with well-established designs) may be Class II or III. Classification depends on risk assessment per RDC 751/2022 Annex I.
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.
Clinical Evidence Requirements: ANVISA typically requires clinical data (clinical trials, published literature, or registry data) demonstrating safety and performance for Class IV implantable devices. The extent of clinical evidence required depends on the device type, risk profile, and whether similar predicate devices exist in Brazil. For novel implantable devices without predicate equivalents, pivotal clinical trials may be required before approval.