Developments in the Field of Medical Devices
On 26 May 2023, significant changes were made to the Medical Device Promotion Regulation. These changes introduced several new procedures to the medical device sector. Rather than being regulated under separate legislation, these procedures were incorporated into the existing Medical Device Promotion Regulation.
According to the updated regulation, additional obligations have been introduced for authorised sales centres for medical devices. These include providing technical services, establishing a quality management system, offering training before the initial use of the device, and issuing warranty certificates. The effective date for these new obligations is 1 January 2025. The Implementation Guide for the regulation includes provisions regarding the issuance of technical service and warranty certificates. If companies fail to comply with these obligations, the penalties outlined in the regulation range from a receiving a warning to the suspension of operations of the sales centre.
On 26 May 2023, the Regulation on Technical Services for Medical Devices Used in Healthcare Services (“Technical Service Regulation”) was also published. This regulation defines the qualifications of technical service providers, authorisation and inspection processes, staff training and obligations. With this new regulation, additional steps such as the preparation, certification, and tracking of training for technical service providers are expected to take place. The Technical Service Regulation will come into effect on 1 June 2026. The criteria set out in the regulation for technical services and the suspension or cancellation of authorised technical service working documents may require revisions to contractual agreements with service providers.
These regulatory changes in the medical device sector are expected to have a significant impact on both the operations of companies and Türkiye’s healthcare infrastructure. The new rules provide an opportunity for companies to operate in a transparent and compliant manner while also aiming to improve the overall quality within the sector. Additionally, the Medical Device Sector Report published by the Agency highlights the current state of the sector, presenting valuable data on rising healthcare expenditures and market development. To enhance Türkiye’s competitiveness in the global medical device market, R&D investments and incentives are seen as critical, although there is an emphasis on the need to increase the production capacity within the country.
These dynamics not only provide medical device companies with opportunities to comply with the new regulations but also encourage the development of strong strategies in R&D and innovation. In the future, these innovations are expected to contribute to the sustainability of the healthcare system and the broader availability of medical devices to the population.