The Circular on Medical Device Regulations (“Circular”) has been published on the Turkish Medicines and Medical Devices Agency’s website (“TMMDA”) on 30 September 2022. TMMDA stated that the Circular aims to clarify the application principles of the provisions brought by the “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation”.
Within the scope of the Circular,
The obligation of undertakings to employ compliance officer,
The obligation to register to EUDAMED the centralized database of the European Union,
Duties and responsibilities of the expert committee,
Notifications required to be made regarding the vigilance system and
Subjects regarding the Product Tracking System registration procedures
are explained.
You can access the Circular and TMMDA’a announcement regarding the Circular from the link below (only in Turkish):