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Legal Alerts

22/04/2021

Recent Developments in the Healthcare Sector

Legal Alerts
Healthcare
Healthcare & Life Sciences

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The Turkish Medicine and Medical Devices Authority (“TİTCK”) published a number of announcements covering critical topics such as new practices for registration, the evaluation process of medical devices post-Brexit, the Product Tracking System (tr. “ÜTS”) registration requirement for medical service providers and the document upload procedure on ÜTS related to medical devices used during the health service provided by health service providers by using the service purchase method.

Please click on the relevant link below for our specific note regarding recent developments:

TİTCK Amends the Updated Practices for the Registration and Evaluation of Medical Devices Post-Brexit
TİTCK Publishes Guidelines for Medical Service Providers

TİTCK Amends the Updated Practices for the Registration and Evaluation of Medical Devices Post-Brexit

Recent Development

On 12 April 2021, TİTCK announced the amendment of practices for registration and the evaluation process of medical devices post-Brexit published on 15 January 2021. TİTCK’s announcement regarding the amendment is available here (in Turkish).

What’s New?

TİTCK’s announcement establishes amended practices for the evaluation of EC certificates issued to medical device companies by the approved organizations that are affected by Brexit and the records linked to these documents.

The announcement elaborates on the following:

  • There will be no restrictions upon the movement of medical devices that are singularized by production or importation declaration through the ÜTS until 8 April 2021. Nonetheless, for single product declarations made after 8 April 2021, if the relevant document is rejected because of a delay in update, the relevant medical device and its relevant documentation must be updated and registered to the system.
  • When medical devices that lose their registration with ÜTS following 8 April 2021 are later registered to the system with a recent EC certificate by another approved organization in accordance with 93/42/EEC, 98/79/EC or 90/385/EEC (“Medical Devices Regulations“); if there are inconsistencies between documents linked with the relevant device, these will not be taken into consideration in the medical device applications. Therefore, the medical device application will not be rejected or will not require revision, depending on the status of the current ÜTS record.

TİTCK Publishes Guidelines for Medical Service Providers

Recent Developments

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

What’s New?  

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

Medical service providers who complete their registration on ÜTS must upload the agreement signed with the health service provider on 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.

Conclusion

TİTCK continues to provide guidance for medical device companies. Companies working on this field must follow TİTCK’s announcements and take the necessary steps to fulfil their obligations.