The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Announcement on Clinical Research Applications and the Fourth Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.
The TİTCK also amended the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices.
Additionally, the Ministry of Health ("Ministry") recently amended the Regulation on Private Health Institutions Providing Outpatient Diagnosis and Treatment and Communiqué on the Principles and Procedures for the Implementation of Intensive Care Services in Inpatient Health Centers.
Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices
On 30 December 2024, the TİTCK updated the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices. The main amendments introduced by the Guideline are as follows:
- Sales centers that have granted an import permit to a different sales center for devices registered in the Product Tracking System ("ÜTS") through the ÜTS will be jointly and severally responsible with the sales center that has granted import permit for the warranty certificate and technical service obligations throughout the lifespan of the devices imported with permit.
- Joint liability will not be sought for the devices for which import permit is not granted through the ÜTS.
- The obligation to issue a warranty certificate will not be sought for medical device accessories that are not sold along with the device.
- The obligation to issue a warranty certificate will not be sought for the sale of a device that has been put into service.
- For devices without a specified lifespan in the warranty certificate, the lifespan will be considered as the period of use by the health service provider, provided that it will not exceed 10 years.
- Persons who are found to have transacted in the registration and information management systems in violation of the rules and procedures determined by the TİTCK will be prevented from registering a medical device registration through the ÜTS until they successfully complete the medical device registrar training and obtain a qualification certificate.
The Guideline is available here (in Turkish).
Announcement on Clinical Research Applications
On 3 January 2025, the TİTCK published the Announcement on Clinical Research Applications. Annual reporting on the progress of ongoing clinical research permitted by the TİTCK from 1 January 2024 to 31 December 2024 will be submitted by 31 January 2025. Annual reporting for researches registered in the clinical research module will be submitted through relevant module, and annual reporting for researches not registered in the clinical research module will be submitted through the Electronic Application System General Document Application by filling out the annual reporting form and cover letter.
The Announcement is available here (in Turkish).
Regulation on Private Health Institutions Providing Outpatient Diagnosis and Treatment
On January 7, 2025, the Ministry published the Regulation Amending the Regulation on Private Health Institutions Providing Outpatient Diagnosis and Treatment. The main amendments introduced by the Regulation are as follows:
- Prior to the amendment, provided that the necessary physical space and minimum medical equipment requirements were complied with, skin and venereal diseases physicians, plastic aesthetic, reconstructive and plastic surgery physicians, and physicians with a medical plastic aesthetic certificate approved by the Ministry could provide plastic aesthetic health services within medical centers, polyclinics and practices. With the amendment, doctors whose training curricula are appropriate and who have obtained competence through certificates will be able to provide plastic aesthetic health services within the scope of the medical practices permitted for the health institution in which they are located.
- The license suspension periods, preliminary license periods and licensing periods for licensed private health institutions have been extended until 30 June 2025.
- Medical centers that have obtained a medical center license through on-site conversion will be able to complete the number of specialist physicians in at least 2 specialties by 30 June 2025, despite the expiration of the 3-year period previously granted to these centers.
- Polyclinics licensed as other than type A or B before 16 January 2024, will have their licenses cancelled unless they renew their licenses as type A or B by 30 June 2025.
The Regulation is available here (in Turkish).
Communiqué on the Principles and Procedures for the Implementation of Intensive Care Services in Inpatient Health Centers
On January 7, 2025, the Ministry published the Communiqué Amending the Communiqué on the Principles and Procedures for the Implementation of Intensive Care Services in Inpatient Health Centers. The main amendments introduced by the Communiqué are as follows:
- Registered or temporarily registered intensive care services that were in operation before 20 July 2011, and intensive care services within healthcare facilities that have hospital preliminary license granted by the Ministry and whose physical infrastructure inadequacy has been documented by a commission report will be exempted from meeting the minimum standards for physical areas in Section 2 of the Communiqué until 30 June 2025.
- Existing cardiovascular surgery intensive care units in private healthcare centers will be required to provide at least 4 intensive care beds, a single-bed contact isolation room, and at least 3 cardiovascular surgery specialists by 30 June 2025.
- Personnel working in operating or newly opened intensive care services who cannot meet the requirement of completing intensive care training will have their status documented with a report. These personnel will be exempt from the intensive care training from 31 December 2019 until 30 June 2025.
- In the neonatal intensive care services of hospitals that have been licensed before 21 August 2020 or whose preliminary license and licensing procedures are ongoing, the conditions of having a maximum of 20 incubators in the same physical area, and for those with more than 20 incubators, a separate service area in a separate physical area for each 20 incubators will be provided until 30 June 2025.
- In hospitals that have been licensed before 21 August 2020, or whose preliminary license and licensing procedures are ongoing, by 30 June 2025 at the latest, except for pediatric intensive care units, in all healthcare facilities with adult intensive care and neonatal intensive care units that are suitable for distribution at more than one level within the scope of the bed number standards specified in Annex-1 and Annex-3 of the Communiqué according to intensive care levels; at least two levels of intensive care units or beds deemed appropriate by the Ministry's schedules will be provided.
The Communiqué is available here (in Turkish).
Fourth Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products
On 9 January 2025, the TİTCK announced the fourth quarter results of its cosmetic sector market surveillance and inspection conducted in October, November and December 2024.
Of the 725 cosmetic products inspected by the TİTCK's Cosmetics Supervision Department, 406 were noncompliant and 9 were risky. The responsible companies were subject to an overall administrative fine of TRY 914,500 (approximately USD 25,652).
Of the 14 type-1 and type-19 biocidal products inspected by the TİTCK's Cosmetics Supervision Department, 3 were noncompliant and 9 were risky. The responsible companies were subject to an overall administrative fine of TRY 1,838,097 (approximately USD 50,569).
The 2024 fourth quarter results for cosmetic products are available here (in Turkish).
The 2024 fourth quarter results for type-1 and type-19 biocidal products are available here (in Turkish).
What Do the Results Say?
The cosmetic products' safety results reveal that both the number of inspected cosmetic products and the number of noncompliant products increased when compared to the results of the third quarter of 2024. In this regard, there was also an increase in the total amount of fines imposed.
The type-1 and type-19 biocidal products' safety results reveal that the both the number of inspected products and the number of noncompliant products has decreased. However, the total amount of administrative fines has increased when compared to the results of the third quarter of 2024.
Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK's announcements and take the necessary actions to ensure compliance.
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