Türkiye updates the electronic-instructions framework for medical devices

Verified facts

• A Ministry of Health publication records the 22 April 2026 amendment to the communiqué on electronic instructions for use for medical devices. The amendment updates defined terminology and provisions in the underlying framework, including treatment of fixed-installation devices.
• The official text is a regulatory change source. Its application depends on the precise device, intended use, user category, language and accessibility conditions, technical documentation, registration status, manufacturer or representative role and the current consolidated rule set.
• U.S. International Trade Administration guidance published in January 2026 describes medical-device registration through Türkiye’s Product Tracking System and notes separate reimbursement and public/private procurement routes. It provides independent operating context, while it does not determine whether an individual electronic-IFU model, device or commercial workflow is compliant.
• Türkiye’s Ministry of Health has separately highlighted domestic medical-device production, quality and strategic cooperation during 2026 industry meetings. That policy context increases the value of a documented quality and information-management approach for each product, but it does not replace the applicable regulatory, clinical, purchasing or contractual evidence.