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 |
BR-unique
ANVISA requires that Class IV implantable devices include a mechanism for patient identification and device traceability — equivalent to the EU MDR "implant card."
Class IV implantable devices require a Post-Market Clinical Follow-Up (PMCF) plan.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.