IMPORTANT CHANGES TO THE REGULATION ON SALES, ADVERTISEMENT AND PROMOTION OF MEDICAL DEVICES

For various purposes such as bringing the obligation to issue a warranty certificate for medical devices to be used in hospitals, expanding the scope of centers where some medical devices are sold in order to facilitate the access of citizens and also improving the liability of the manufacturers and importers, some amendments have been brought through the Regulation on the Amendment of the Regulation on Sales, Advertisement and Promotion of Medical Devices (in Turkish, “Tıbbi Cihaz Satış, Reklam Ve Tanıtım Yönetmeliğinde Değişiklik Yapılmasına Dair Yönetmelik”, the “Amendment Regulation”) that has been published in the Official Gazette on 26 May 2023.

We can briefly list as follows some of the significant changes that have been introduced with this Amendment Regulation:

• Through article 3 of the Amendment Regulation,  new definitions such as, “exporter”, “importer”, “warranty certificate”, “using guide”, “misuse”, “economic life”, “technical service”, “technical service training”, “technical service activities” “sales centers” etc. have been added to the Regulation on Sales, Advertisement and Promotion of Medical Devices and also the scope of  some of already existing definitions have been expanded, such as the definition of the Health Service Provider.
• Through article 4 of the Amendment Regulation, an obligation has been brought to the applicants that manufacture medical devices in the domestic market to submit a certificate indicating that they have established and  been implementing a quality management system within the scope of the « EN ISO 13485 Quality Management System for Medical Devices » standard issued by a conformity assessment body accredited by an accreditation body authorized under Regulation (EC) No. 765/2008 of the European Parliament and of the Council Regulation which establishes the requirements for accreditation and market surveillance. As a side note, this article shall enter into force on 1 January 2027.
• As per article 6 of the Amendment Regulation, if required in writing by health service providers, the sales centers which are the places where the devices are sold, are obliged to directly give or to organize a third party to give a free training to the health service providers before first use for the devices they have manufactured or imported.  These provisions brought with article 6 shall enter into force on 1 January 2025.
• As per article 7 of the Amendment Regulation, sales centers are obliged to issue a warranty certificate in a clear, simple, and legible manner. The liability of proving the existence of such a warranty certificate lies with the sales centers. The duration of the warranty certificate shall be at least 2 (two) years or the value determined by the measurement unit stipulated by the manufacturer of the device. The provisions in relation to the warranty certificate shall enter into force on 1 January 2025.

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