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, free of charge, 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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