Medical Device Registration and Approval in Turkey

General country-specific regulatory information is provided on this page for medical device registration and approval in Turkey. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Turkey, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Turkey

REGULATORY AUTHORITY: Medical device registration is handled by TITUBB, the Turkish National Database for Medical Devices.

CLASSIFICATION: Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The approval process takes about 3-5 months.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: Translation and legalization of all documents should be carried out by a Turkish company.

Last updated on March 17 2015.

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