🇹🇷Turkey Medical Device Regulations

Turkish Medicines and Medical Devices Agency (TİTCK)

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IVD Medical Device Regulation, Official Gazette No. 31499

IVD

Turkish In Vitro Diagnostic Medical Device Regulation

Turkish IVD framework aligned with Regulation (EU) 2017/746, including risk classification, conformity assessment, performance evidence, registration, and post-market requirements.

TİTCK (Turkey)Effective: May 26, 2022Doc: Turkish

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Medical Device Regulation, Official Gazette No. 31499

General

Turkish Medical Device Regulation

Turkey’s core medical device regulation, aligned with Regulation (EU) 2017/745, covering classification, conformity assessment, economic operators, UDI, market access, and post-market obligations.

TİTCK (Turkey)Effective: May 26, 2021Doc: Turkish

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ÜTS Requirements

Registration

Product Tracking System Registration Requirements

Requires relevant manufacturers, authorized representatives, importers, devices, and conformity information to be recorded and maintained in Turkey’s national Product Tracking System (ÜTS).

TİTCK (Turkey)Doc: Turkish