Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency
Number: 71146310-[ Internal ]
Subject: Clinical Trials of Medical Devices
ANNOUNCEMENT
As is known, Article 35 of the Regulation on Clinical Research published in the Official Gazette dated April 13, 2013, and numbered 28617, repealed the Regulation on Clinical Research published in the Official Gazette dated August 19, 2012, and numbered 28030. Medical Device Clinical Research and Performance Evaluation Studies are not included within the scope of the Regulation on Clinical Research published in the Official Gazette dated April 13, 2013, and numbered 28617. Matters related to Medical Device Clinical Research and Performance Evaluation Studies are governed by the Annex to the Basic Law on Health Services published in the Official Gazette dated April 26, 2011, and numbered 27916. Article 10 shall be implemented in accordance with the Medical Devices Regulation and the Regulation on Implantable Active Medical Devices published in the Official Gazette dated 07/06/2011 and numbered 27957, and the Regulation on In Vitro Diagnostic Medical Devices published in the Official Gazette dated 09.01.2007 and numbered 26398, and related regulations.
In this context, the regulatory provisions regarding clinical trials of medical devices are included in Article 10 of the Annex to the Basic Law on Health Services, Article 15 of the Medical Devices Regulation, and the Clinical Evaluation sections of Annex X of the same regulation; Article 10 of the Annex to the Basic Law on Health Services states that "In order for any treatment method or means, or even drugs and formulations, traditional herbal medicinal products and medical devices, to be used on humans for scientific research purposes, in addition to obtaining permission from the Ministry of Health, the research to be conducted must be approved by the relevant ethics committee." Furthermore, Article 15, paragraph 2 of the Medical Devices Regulation states that "The manufacturer shall notify the Ministry of the request for clinical research regarding Class III medical devices and implants and long-term invasive devices included in Class IIa or IIb, together with the approval of the relevant Ethics Committee. The Ministry shall finalize the clinical research request 60 (sixty) days after the notification date," and paragraph 3 states that "If the relevant Ethics Committee gives a positive opinion by adding its own justification to the research plan, the Ministry may grant permission to the manufacturer to initiate the clinical research without waiting for the expiration of the 60 (sixty) day period." In addition to these statements, Article 2.2 of Annex X of the same regulation states: “Ethical Assessments; Clinical research must be conducted in accordance with the Helsinki Declaration, adopted at the 18th World Medical Assembly in Helsinki, Finland in 1964 and whose final amendments were made at the World Medical Assembly. All measures aimed at protecting human health must be implemented within the framework of the Helsinki Declaration. This declaration covers every stage of clinical research, from the moment the need is recognized and the study is justified until the publication of the results.”
In conclusion, as briefly summarized above, when conducting Medical Device Clinical Trials in accordance with the relevant articles of the Law and Regulations regulating Medical Device Clinical Trials;
Republic of Turkey
MINISTRY OF HEALTH
Turkish Medicines and Medical Devices Agency
__________________________________________________________________________
Sögütözü Neighborhood, 2176th Street No:5 06520 Çankaya/ANKARA
Tel: (0 312) 218 30 00– Fax : (0 312) 218 34 60
1- Medical device clinical trials can be conducted in accordance with the aforementioned laws and regulations currently in force.
2- According to Article 10 of the Annex to the Basic Law on Health Services, all clinical trials of medical devices, including observational clinical trials, cannot be conducted without the approval of the Ethics Committee and the permission of the Institution.
3- In accordance with the provision of “Temporary Article 1 – (1) Ethics committees approved in accordance with the Regulation on Clinical Research published in the Official Gazette dated 19/8/2011 and numbered 28030 can continue their duties for a maximum of six months from the date of publication of this Regulation” of the Regulation on Clinical Research published in the Official Gazette dated 13 April 2013 and numbered 28617, Ethics Committees that have previously received approval from our institution can evaluate applications related to Medical Device Clinical Research and Performance Evaluation Studies until the aforementioned date.
4- Due to the repeal of the Regulation on Clinical Research published in the Official Gazette dated 19.08.2012 and numbered 28030, and the absence of any contrary statement in the current legislation, interested parties may apply for ethical committee approval to any Clinical Research Ethics Committee approved by the Turkish Medicines and Medical Devices Agency without any restrictions.
5- Due to the provisions in Article 10 of the Basic Law on Health Services and Article 15 of the Medical Devices Regulation, applications for institutional approval, which is mandatory for clinical trials of medical devices, can only be made after receiving a positive opinion from the relevant ethics committee.
6- In accordance with Article 10 of the Annex to the Basic Law on Health Services, clinical trials of relevant medical devices can be conducted in university health application and research centers, approved research and development centers affiliated with universities, and Ministry of Health training and research hospitals, provided that these centers have personnel, equipment, and laboratory facilities suitable for ensuring the safety of the researchers, conducting the research properly, monitoring it, and providing emergency intervention when necessary, and that are appropriate to the nature of the research.
7- Performance evaluation studies to be conducted by the manufacturer to support and validate the performance claims of in vitro diagnostic medical devices can only be initiated after receiving positive scientific opinions from ethics committees authorized by our institution and notification to our institution.
8- All relevant studies must be conducted in accordance with Good Clinical Practice principles, within the framework of the provisions specified in the international agreements to which Turkey is a party.
- Applications to the institution must be made using the most up-to-date forms and documents published on the institution's website.
10- Applications for clinical research of medical devices to be made to the Turkish Medicines and Medical Devices Agency will be finalized within sixty (60) days at the latest, in accordance with medical device regulations.
These factors must be taken into consideration.
This is hereby brought to the public's attention.
…/…./2013
Dr. Saim Kerman
Head of Institution
__________________________________________________________________________
Sögütözü Neighborhood, 2176th Street No:5 06520 Çankaya/ANKARA
Tel: (0 312) 218 30 00– Fax : (0 312) 218 34 60
