The Turkish Ministry of Health has announced that the Product Tracking System (PTS) will be implemented in accordance with the provisions of the Regulation on the Amendment of the Medical Device Sales, Advertising, and Promotion Regulation (ÜTSG-2023/3).

The PTS is a web-based system that will track the movement of medical devices from the manufacturer to the end user. The system will be used to ensure the traceability of medical devices, to prevent counterfeiting, and to facilitate the recall of medical devices in the event of a safety issue.

Companies that sell medical devices in Turkey will be required to register with the PTS. In order to register with the PTS, companies will need to have a medical device sales center license. The license is issued by the Provincial Health Directorate in the province where the company is located.

Companies that are already registered with the PTS as "Manufacturer/Importer/Dealer/Exporter" will need to update their registration to include their CRMS number by 26 May 2024. The CRMS number is the unique identifier for a medical device sales center.

Companies that do not update their registration by the deadline will have their registrations in the PTS deactivated.

The implementation of the PTS is a significant step forward in the regulation of medical devices in Turkey. The system will help to ensure the safety and quality of medical devices in the Turkish market.

In addition to the above, here are some other key points to note:

  • The PTS is a web-based system that will be accessible to all stakeholders in the medical device supply chain.
  • The system will collect data on the movement of medical devices, including the manufacturer, importer, distributor, and end user.
  • The PTS will be used to prevent counterfeiting and to facilitate the recall of medical devices in the event of a safety issue.
  • Companies that sell medical devices in Turkey will be required to register with the PTS.
  • The deadline for updating registrations in the PTS is 26 May 2024.

Companies that are unsure whether they need to register with the PTS or how to update their registration should contact the Provincial Health Directorate in their province.

The implementation of the PTS is an important step in the regulation of medical devices in Turkey. The system will help to ensure the safety and quality of medical devices in the Turkish market. Companies that sell medical devices in Turkey should ensure that they are registered with the PTS and that their registration is up-to-date.