Medical Device Regulatory Requirements in Turkey
| Regulatory Authority |
Turkish Medicines and Medical Devices Agency, Ministry of Health (TITCK) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
New Medical Device Regulation
| Click Here
|
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Turkish |
| Additional Information |
In accordance with Articles 8 to 11 of Decision No 1/95 of the EUTurkey Association Council establishing the Customs Union between Turkey and the European Union (EU), it had been decreed that Turkey should include the EU's technical legislation on products into its domestic law. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025