Turkey-TITCK
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1. Administration and Abstract
The administration for medical devices in Turkey is the Turkish Medicines and Medical Devices Authority TITCK (Turkiye lac ve T bbi Cihazlar Kurumu). The main responsibilities of TITCK are: market access audit of medical devices, regulatory development and enforcement, market supervision and follow-up audit.
2. Administrative Regulation
Tibbi Cihaz Yönetmeliği, Official Gazette No. 31499.
As required by the Turkish Medical Devices Regulation, Turkish medical device registrations are also subject to the EU MDR 2017/745 (Medical Devices Regulation) and IVDR 2017/746 (In Vitro Diagnostic Medical Devices Regulation).
3. Risk Level Classification of Medical Device and IVD Products
The Turkish medical regulatory authority classifies medical devices into: Class I, Class IIa, Class IIb and Class III:
The Turkish Medical regulatory authority classifies IVDs into: Class A, Class B, Class C and Class D:
4. Registration Basis
Turkish medical device registration regulation requires that imported products must have passed CE registration or approval, affixed CE mark, and registered medical devices in the EUDAMED database.
5. Registration Language
Turkish.
6. Turkish holder
According to the relevant regulations of Turkey, a Turkish medical device holder is a legal person or entity responsible for the registration of medical devices in Turkey and holds a Turkish medical device registration certificate.
Chapter 2 Registration Flow
Chapter 3 Cycle & Official Fee
The registration period for medical devices /IVD in Turkey is 1-6 months
Official fee:
Chapter 4 FAQ
Q: How long does it take to register medical devices in Turkey?
A: 1-6 months.
Q: Does it require a QMS certificate to register a medical device in Turkey?
A: Yes.
Q: Can the registration of medical device products be changed after registration?
A: If the medical device product changes meet the requirements, registration changes can be made according to the procedure.