The Regulation Amending the Regulation on Medical Device Sales, Advertisement and Promotion
The scope of medical devices, their sale to third parties, the scope and limitations of advertising and promotion activities are regulated by the Regulation on Medical Device Sales, Advertisement and Promotion (“Regulation”) issued by the Turkish Medicines and Medical Devices Authority (“Authority”).
The Regulation Amending the Regulation on Medical Device Sales, Advertisement and Promotion (“Amendment Regulation”) was published on the Official Gazette dated 26.05.2023 and numbered 32202.
Devices within the scope of Regulation on In Vitro Diagnostic Medical Devices have been added to the scope of the Regulation and the definition of medical device with the aforementioned Amendment Regulation.
In addition, the Amendment Regulation regulates new provisions regarding the production and maintenance of medical devices, new definitions such as "use life, usage error, technical service, spare parts" and the obligations of the seller and importer and/or manufacturer after the sale of medical devices. Accordingly, some of the obligations imposed on the seller and importer and/or manufacturers are as follows:
Manufacturers producing medical devices in Turkey are obliged to submit a document showing that they have established and implemented the quality management system within the scope of the "EN ISO 13485 Quality Management System in Medical Devices" standard. (enters into force on 01.01.2027.)
Except for the devices that do not require technical service activities, sales centers are obliged to issue a guaranteed certificate in an understandable language, in a clear, plain, and readable manner, in accordance with the provisions of the Regulation, for the devices to be used within the scope of the health service provision of which they are manufacturers or importers.
Sales centers provide or ensure that the basic technical training of the devices which they are the manufacturer or importer of has been provided free of charge and for once before the first use, upon the written request of the relevant health service provider. (enters into force on 01.01.2025.)
Sales centers may provide technical service training for the devices they are manufacturers or importers of throughout their lifetime at a price. (enters into force on 01.01.2025.)
The healthcare provider has the right to request free repair for the device during the currency of the warranty certificate. The sales centers in the supply chain of the device are responsible for the fulfillment of this request and cannot charge any fee under any name such as labor cost, part replacement or carriage. In case the health service provider uses the right to free repair, the health service provider may request a refund or replacement of the device with an unused product from the sales center, which is the manufacturer or importer of the device on condition where the manufacturer or importer of the device, the sales center, or the authorized technical service of the device, determines that the repair is not suitable, or the total time spent in the repair exceeds the annual maximum total repair period.
All sales centers that supply and keep the sanctioned product on the market are jointly responsible for the implementation of the administrative sanction decisions taken by the Authority within the scope of the Regulation or Law w. No. 7223.
However, it is regulated that exceptions can be made by the Authority regarding obligation and restrictions in the Regulation concerning the sale, advertisement, and promotion of medical devices as for device requests by public institutions and organizations and in cases that will occur against public health hazard recognized by the World Health Organization or the European Union or accepted by the Ministry of Health.
In summary, the scope of the regulations regarding the sale, advertisement and promotion of medical devices has been expanded and some additional obligations regarding sales and after-sales support have been introduced for sellers, importers and/or manufacturers selling medical devices with the Amendment Regulation.
The amendments brought by the Amendment Regulation entered into force on 26.05.2023 (except those stated otherwise).
You can access the Amendment Regulation through the link below:
Authors: Hatice Ekici Tağa, Ebru Gümüş