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