Turkiye
- Regulatory Authority:
Turkish Medicines and Medical Devices Agency (TMMDA)
- Legislations:
Regulation on Medical Device: Published in the Official Gazette dated 02 June 2021 No.31499
Regulation on InVitro Diagnostic Medical Devices: Published in the Official Gazette dated 02 June 2021 No.31499
Закон о регулировании медицинских изделий
- Certificate validity period:
similar to the validity period of the CE
- Language of labeling and documentation:
Turkish
- Registration period:
2–3 months
- Authorized Representative:
country resident
A brief algorithm for registration of medical devices in Turkiye:
02
Preparation of Power of Attorney on the name of the company that will act as Authorized Representative
04