Turkish Medicines and Medical Devices Agency’s Announcement to Conformity Assessment Bodies Operating in the Field of Medical Devices
The Regulation on Conformity Assessment Bodies and Notified Bodies (“Regulation”) was published in the Official Gazette dated May 27, 2021, and numbered 31493. With this Regulation, the minimum qualifications, working procedures and principles of the organizations that inspect, test, and certify the conformity of a product with the relevant technical regulation through conformity assessment, and the notified bodies assigned among them, and notification to the relevant parties per Turkey’s international obligations are regulated. In addition, the Regulation defines a conformity assessment body as the organization that performs conformity assessment activities, including calibration, testing, certification, and inspection.
As per the Regulation, conformity assessment bodies are obliged to inform the authorized bodies responsible for the technical regulation in which they operate. Accordingly, a conformity assessment body, which has just started its activities, shall notify the relevant authorized body within one month of its field of activity and contact information. If there is a change in the information they report, the notification shall be repeated within one month. Authorized bodies shall ensure that the notification is made in a way that does not create an additional financial burden for conformity assessment bodies and forward the notifications made to them to the Ministry of Trade.
Finally, upon the provision in the Regulation that the existing conformity assessment bodies shall notify the relevant authorized body within two months from the date of entry into force of the Regulation, including the field of activity and contact information, Turkish Medicines and Medical Devices Agency (“TITCK”) announced that conformity assessment bodies operating in the field of medical devices in Turkey should send their fields of activity and contact information to TITCK electronically until December 3, 2021.