Guide on the Implementation of Medical Device Sales, Advertising and Promotion Regulations

Purpose
The Medical Device Sectoral Services Department of Turkey has published an updated guide, effective from December 31, 2024, replacing Version No:3 with Version No:4 of the Regulation Guide for the Implementation of the Medical Device Sales, Advertising and Promotion Regulation. This change aims to harmonize the rules and regulations within the medical device sector.

Effects on Industry
The update has introduced modifications in several areas, including warranty certificate issuance and technical service responsibilities, as well as requirements for product tracking system registration by individuals or entities. These amendments are expected to have a significant impact on businesses involved in the production, sales, and maintenance of medical devices, necessitating adjustments to their operational procedures and policies.

Relevant Stakeholders
This update affects various stakeholders within the medical device sector, including manufacturers, distributors, healthcare providers, and consumers. Businesses operating in this space must ensure compliance with the revised regulations to avoid any potential penalties or reputational damage. Specifically, companies involved in the production, sales, and maintenance of medical devices are directly impacted.

Next Steps
To comply with these changes, businesses should review their current practices and procedures to identify areas requiring modification. This may involve updating training programs for employees, revising product labeling and marketing materials, and ensuring seamless integration with the updated Product Tracking System. Companies are also advised to monitor regulatory updates and engage in ongoing compliance efforts to maintain their competitive edge.

Any Other Relevant Information
The Turkish government’s continued efforts to strengthen regulations within the medical device sector demonstrate a commitment to enhancing patient safety and promoting trust in healthcare products. As more countries adopt similar measures, it is essential for businesses operating globally to remain aware of these developments and adapt their strategies accordingly.