The Regulation on the Sale, Advertisement, and Promotion of Medical Devices (“Medical Device Promotion Regulation”), the legislation containing detailed provisions on the sales, advertising, and promotion activities of companies, was significantly amended on May 26, 2023, and introduced number of new procedures to the medical device sector. These procedures, which are not essentially considered as promotional activities, are governed by the Medical Device Promotion Regulation rather than being regulated in a separate legislation
According to the new provisions of the Medical Device Promotion Regulation, sales centers authorized to sell medical devices are obliged to provide technical services, establish a quality management system, offer training before first use of the device, and issue warranty certificates. As the effective date of these new obligations has been set as January 01, 2025, it is thought that the implementation will be clarified with announcements to be made by the Agency when the effective date approaches. The sanctions to be imposed in case of non-compliance with these new obligations increase gradually, starting with a warning, and can reach severe sanctions, such as suspension of activities of the sales center.
On May 26, 2023, the Regulation on Technical Services for Medical Devices Used in the Scope of Healthcare Service Provision ("Technical Services Regulation") was published and regulated the qualifications, authorization and audit processes, personnel training and obligations of technical services for medical devices. With the new regulation, new processes are expected to occur such as the preparation, certification and monitoring of training in the appointment of technical services. In addition, the Technical Service Regulation, which will enter into force on June 1, 2026, may require revisions in the contracts with technical services in accordance with the technical service criteria and the suspension and revocation of the certificate of authorized technical services.