UTS Cosmetic & Medical Device Registration

UTS Medical Device & Cosmetic Notifications

UTS; The Product Tracking System is managed by the Republic of Turkey, Ministry of Health, Turkey Pharmaceuticals, and Medical Devices Agency. With the product tracking system UTS Notifications, the entry of medical devices and cosmetic products into the country is under control. Medical device and cosmetic needs, in general, become more traceable with UTS. In addition, UTS prevents attempts to produce counterfeit cosmetics and medical devices.
Registration in the product tracking system is the legal obligation of manufacturers of medical devices and cosmetics. For UTS registration of medical devices, companies must first register with UTS. Product registration is completed after company registration.

Technical File

Medical device technical files should be kept for ten years. The technical files of the products for which a UTS notification will be made should be prepared in Turkish. Technical file contents are reported from the eps (e-application system) site.

Medical device Technical file details;
Specifications and definition of the medical device
Design and manufacturing information of the medical device
General safety and performance requirements of the medical device
Benefit-risk analysis and risk management of the medical device
Validation of the medical device and Product validation
Information to be provided by the Manufacturer for the medical device

Necessary information for the UTS system;

• Product Name of the medical device
• Product reference/catalogue code of the medical device
• Product Description
• Number of products in content
• Information on the country of origin of medical devices
• Regulation and class information
• GMDN Code and Branch Type of the medical device
• Images of medical device
• Product Brand
• Importer or Manufacturer information
• Product Label
• Medical device Version or Model
• Product Number

Medical device company registration; medical device product registration, UTS notifications, product tracking system, UTS medical device registration directory, all things to know about UTS.

“For all questions and service requests to UTS Cosmetic & Medical Device Registration, you can write to us via the contact form.”