WARRANTY CERTIFICATES FOR MEDICAL DEVICES

The Regulation on the Amendment of Sale, Advertising and Promotion of Medical Devices Regulation was published in the Official Gazette No. 32202 on May 26, 2023.

This amended Regulation is intended to improve the production standards of our domestic manufacturers by also encouraging the access to safe products.

By this regulation, it is required for the health service provides to issue warranty certificates for medical devices, except for the devices without the need for technical service activities. The burden of proof for the fulfillment of this warranty requirement lies on the sales centers.

The warranty period will be at least two years or the value determined by the unit of measurement stipulated by the manufacturer of the device.

It should be noted that in case of violation of Articles 25/A, 25/B, 25/C or 25/Ç of the Regulation, the sales center is initially warned and granted 90 days for the elimination of the violation. Unless the violation is eliminated, the sales activity of the sales center is temporarily suspended for thirty days except for particular circumstances.

The Regulation will be effective on the date of publication whereas the following Article will enter into force January 01, 2025;

• Articles 6, 7, 8,9
• 2^nd, 3^rd, 4^th paragraphs of Article 25
• 9^th and 10^th paragraphs of Article 26
• 7^th, 8^th, 9^th paragraphs of Article 28

Finally, Article 4 will enter into force on January 01, 2017 and Article 5 on the three months later from the publication.

Sources:

https://www.titck.gov.tr/duyuru/saglik-hizmet-sunumu-kapsaminda-kullanilan-tibbi-cihaz-satis-reklam-ve-tanitim-yonetmeliginde-degisiklik-yapilmasina-dair-yonetmelik-26052023161405