The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements on the testing, control and calibration of medical devices as well as the Investigational Medicinal Product Dossier that must be submitted during clinical researches.
Please click on the relevant link below for our specific note regarding recent developments:
Modifications to the Assignment of the Testing, Control and Calibration Institutions
On 25 August 2015, the TİTCK published a new announcement concerning the tasks of the testing, control and calibration institutions (“Institutions“) assigned as per the Regulation on the Testing, the Control and the Calibration of the Medical Devices (“Regulation“) published on the Official Gazette No. 29397 on 25 August 2015. The relevant announcement is available here (in Turkish).
Under the Regulation, only Institutions assigned by the TİTCK may test, control and calibrate medical devices. However, Article 10(3) of the Regulation entitles the TİTCK to cancel this obligation temporarily if the number of assigned Institutions is insufficient to address the need in practice.
Indeed, the two Institutions assigned by the TİTCK have insufficient capacity to test, control and calibrate medical devices. To this end, the TİTCK has cancelled the obligation of assigned Institutions to test, control and calibrate certain medical devices such as tomographs, aspirators and cardiac pacemakers. The announcement includes a list of the relevant medical devices.
The TİTCK publishes Draft Investigational Medicinal Product Dossier
The TİTCK published through the announcement of 25 August 2021, a draft prepared in order to guide and to be used while preparing the Investigational Medicinal Product Dossier (IMPD) that must be submitted during the clinical trials. The draft IMPD is available here (in Turkish).
The draft instructs clinical trial groups on how to craft the content of an IMPD. In particular, the draft IMPD contains blank sections to be filled in by clinical research groups but has section titles that should reasonably be included in an IMPD. In addition, the draft provides instructions on how the content of the sections should be created as well as how the chapters should be filled. However, the draft only serves an example and does not suffice for the completion of an actual IMPD. In cases where it is not possible to submit data on any topic under any chapter, this should be stated separately in the IMPD along with the scientific justification.
The TİTCK continues to provide guidance for companies working in the medical industry. Companies should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.