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The Turkish medical device regulatory authority

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The Turkish medical device regulatory authority is the Turkish Agency for Medicines and Medical Devices (TITCK, Türkiye İlaç ve Tıbbi Cihazlar Kurumu). The main responsibilities of TITCK are: market access review for medical devices, formulation and implementation of regulations, market monitoring and subsequent review.

Regulatory Authority's Official Website Link:https://www.titck.gov.tr/

Administrative Regulation

Tibbi Cihaz Yönetmeliği, Official Gazette No. 31499 [Medical Device Regulations, No. 31499 Official Gazette]

According to the requirements of the Turkish medical device regulations, Turkish medical device registration also needs to comply with the EU MDR 2017/745 (the Medical Devices Regulation) and IVDR 2017/746 (the In Vitro Diagnostic Medical Devices Regulation).

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:

Registration Basis

According to the regulatory requirements for medical device registration in Turkey, imported products must have already obtained CE registration or certification, affixed the CE mark, and registered for medical devices in the EUDAMED database.

Registration Language

Turkish.

Turkish holder

According to the relevant regulations of Turkey, a Turkish medical device license holder refers to a legal person or entity that is responsible for the registration application of medical devices within Turkey and holds a Turkish medical device registration certificate.

Registration process, cycle and official fees

1. Registration Flow

1. 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.

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