Turkey: TİTCK publishes guidelines for medical service providers

In brief

The Turkish Medicine and Medical Devices Authority (TİTCK) published two announcements covering critical topics on certain procedures concerning the Product Tracking System (ÜTS).

Recent developments

On 12 April 2021, TİTCK published two guidelines. The first was on registration procedures for medical service providers to register on ÜTS and the second on the document upload procedure regarding medical devices used in the health service, provided by health service providers, by using the service purchase method on ÜTS. TİTCK's guidelines for registration of medical service providers on ÜTS are available here (in Turkish) and TİTCK's guidelines for ÜTS transactions of medical service providers are available here (in Turkish).

What's new?

Health service providers may purchase services in the screening, laboratory or dialyze fields. The companies that provide services to health service providers in those fields must have a company registration on ÜTS. The registration of a company is made through the "Application" module (https://utsuygulama.saglik.gov.tr/) by the authorized signatory. The guidelines explain the registration steps for companies with a Central Registration System (MERSIS) registration, for companies that do not have a MERSIS registration and for ordinary partnerships.

Medical service providers that complete their registration on ÜTS must upload the agreement signed with the health service provider to the system. Following that, the medical service provider must delist all products used during the execution of the agreement by a "Consuming Declaration" through ÜTS. Additionally, all medical fixtures used during the execution of the agreement must be added as an annex to the agreement to enable the traceability of fixture used in different medical institutions. The guidelines provide detailed assistance to complete the mentioned processes by using visual examples.

Contact Information
Can Sozer
Associate at BakerMcKenzie
Yigit Acar
Junior Associate at BakerMcKenzie
Ayca Dogu
Junior Associate at BakerMcKenzie

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