The Turkish Medicines and Medical Devices Agency (the “TİTCK”) recently published on its website a draft Regulation on Monitoring and Tracking of Medical Devices (the “Regulation”). Companies may comment and provide feedback on the draft Regulation by filling out the form provided on the TİTCK’s website and returning it by post or through e-mail.
What the Regulation says
Based on Law No. 4703 on Preparation and Application of Technical Legislation of Products, the Regulation sets out the procedures and principles for registering, monitoring and tracking medical devices. In this regard, the Regulation requires all companies and real persons engaged in the manufacture, import, export, sale, distribution, maintenance and repair of medical devices, as well as the medical devices themselves, to be registered with the TİTCK. Persons subject to the registration requirement are required to:
- carry out commercial activities,
- obtain an electronic or mobile signature, and
- submit the necessary information and documents to be required under the guidelines to be published based on the Regulation.
During the registration process, the manufacturer of the relevant medical device (or if the manufacturer is not located in Turkey, the importer of the medical device) is required to provide the necessary information and documents regarding the medical device, its manufacturer and representative of the manufacturer, if any.
The TİTCK also requests certain information and documents regarding the medical devices, such as EC certificate, declaration of conformity, label, user manual, as well as any other information deemed necessary by the TİTCK.
Medical devices that have been placed on the Turkish market prior to the publication of the Regulation will be registered in accordance with the procedures and guidelines to be established by the TİTCK.
Following the registration of medical devices, registered persons and companies must also notify the TİTCK of the manufacture, import and any movement of the medical devices in accordance with the guidelines to be published by the TİTCK.
The implementation of the Regulation and the registration system will gain more certainty once the Regulation takes effect along with the guidelines to be published by the TİTCK. Medical device companies, therefore, should closely follow further announcements of the TİTCK, consider how these new requirements may affect their activities, and benefit from this opportunity by cooperating with the TİTCK to further improve the draft Regulation before its publication.