Compliance Quarterly Türkiye

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Türkiye

Regulations on Medical Devices and the In Vitro Diagnostic Medical Devices is Amended

As part of efforts to align with the European Union acquis, several amendments were made to the Regulations on Medical Devices and In Vitro Diagnostic Medical Devices (Regulations) on August 17, 2024.

The changes to these Regulations reflect measures taken by the European Commission to facilitate the supply of medical devices and align with EU standards particularly regarding the implementation of EUDAMED (European Commission’s database used for the registration, monitoring, and management of medical devices and in-vitro diagnostic devices), supply disruptions and transitional provisions. Additionally, through the amendments, approved institutions will become subject to a full re-assessment process every five years to evaluate their compliance with the Regulations and to maintain quality and conformity standards. The Turkish Medicines and Medical Devices Authority will also have the right to conduct this evaluation before the designated periods if there are any concerns.

Moreover, the notification confirming the fulfillment of obligations and requirements for each of the electronic systems included in EUDAMED must be submitted within six months from the date of its publication in the Official Gazette of the EU.

The list of reimbursable medicine is amended

The Reimbursable Drugs List that is prepared according to the Drug Reimbursement Regulation, regulates the reimbursement procedures for medications under SGK’s health insurance, allowing insured individuals to obtain specific medications within certain rules. The drugs included in this list are generally selected based on health needs, treatment types and the effectiveness of the medications. According to the announcement made, by the General Directorate of General Health Insurance of the Republic of Türkiye Social Security Institution on September 25, 2024, amendments have been made to the Reimbursable Drugs List in accordance with Article 12 of the Regulation. Accordingly, several drugs have been removed, included and/or activated.

Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices is amended

According to the announcement by the Turkish Medicines and Medical Devices Authority (Authority) on October 25,2024, amendments have been made to the “Regulation on Quality Conformity and Quality Control Tests for Diagnostic Radiology, Nuclear Medicine, and Radiotherapy Group Medical Devices” (Regulation). Accordingly, starting from December 23, 2024, the obligation for “Diagnostic Radiology and Nuclear Medicine Group Devices” (Devices) to have their quality conformity and quality control processes conducted by authorized persons and organizations has been temporarily revoked until the next announcement from the Authority. Hence, the quality control and quality conformity processes for these Devices will be conducted based on national and international protocols, guidelines, standards, and the manufacturer’s criteria.