REGULATORY AUTHORITY: Medical device registration is handled by Turkish Medicines and Medical Devices Agency (TITCK)
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.