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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.
Last updated on November 16th, 2021.
Medical Device Regulations and Classification in Turkey
REGULATORY AUTHORITY: Medical device registration is handled by Turkish Medicines and Medical Devices Agency (TITCK)
CLASSIFICATION:
Medical devices: Classes I, IIa, IIb, and III.
IVDs: List A/List B
TIMEFRAME: Product Notification in Product Tracking System (UTS) will take approximately 1 week.
SPECIAL REQUIREMENTS: Not applicable
LOCAL FEES (New Application): No fee is required for the product notification.
LOCAL FEES (Manufacturer): Not applicable.
LICENSE VALIDITY: No validity. Renewal is not applicable, unless there is a significant change to the product or should the EC certificate be renewed or changed.
LICENSE TRANSFER: Not applicable
AUTHORIZED REPRESENTATIVE: Manufacturers without local presence in Turkey must appoint a local Authorized Representative (AR) who is responsible for the registration and becomes the license holder (LH). This AR will also act as the product importer and/or distributor.
ADDITIONAL INFORMATION: EC Certificate / CE Mark is mandatory. Only Product Notification in Product Tracking System (UTS) is required.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey
For detailed device-specific compliance information for each market, including Turkey, to expedite the preparation of your medical device or IVD registration application.
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