Approvals and certificates explained
What FDA clearance, a CE mark and other approvals do, and do not, tell you.
Key point: an approval means an implant may legally be sold. It does not mean it has been proven better than others, or that it has long-term studies behind it.
| Approval | What it means |
|---|---|
| FDA 510(k) clearance (USA) | The US Food and Drug Administration clears an implant after the maker shows it is 'substantially equivalent' to one already on the market. Clearance is not the same as proving it is better, or that it has long-term clinical studies. |
| CE mark under EU MDR (Europe) | Required to sell in the EU. Since 2021 the Medical Device Regulation demands more clinical evidence and post-market follow-up than the old rules. |
| UKCA (United Kingdom) | The UK's post-Brexit marking. CE-marked devices are still accepted in Great Britain for a transition period. |
| Health Canada licence | Implants are Class III devices in Canada and need a medical device licence. |
| TGA (Australia) | Implants must be listed on the Australian Register of Therapeutic Goods. |
| KFDA/MFDS (South Korea) | Korean approval, held by all Korean manufacturers. |
| ANVISA (Brazil) | Brazilian regulatory approval. |
| TİTCK (Turkey) | The Turkish Medicines and Medical Devices Agency registration. |
See also: technical standards.