On 26 May 2023, the Turkish Medicines and Medical Devices Agency (Agency) published the Regulation on Technical Services for Medical Devices Used for Provision of Healthcare Services (Turkish language) (Regulation) in the Official Gazette numbered 32202.
The Regulation has been prepared by the Agency to regulate the qualifications, authorisation, supervision and training of technical services that will support activities such as installation, updates, upgrades, modification, maintenance or repair of medical devices used in healthcare services. It will also regulate the qualifications and training of the relevant personnel working in these technical services and determine the obligations of technical services and healthcare service providers.
The Regulation entered into force on the date of its publication, however, the Agency has granted a transition period to ensure smooth compliance by stipulating that medical device technical service activities must comply with provisions of the Regulation by 1 June 2026. The Agency also expects to publish a guideline on the implementation of the Regulation.
First published by Practical Law Life Sciences Monthly Newsletter in Jul 04, 2023.