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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