The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published (i) the Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision, (ii) the Regulation on Clinical Trials of Pharmaceuticals, (iii) the Regulation on the Marketing Authorization of Advanced Therapy Medicinal Products, (iv) the Regulation on Market Inspection of Pharmaceuticals, (v) the Regulation on the National Serial Release, (vi) the Regulation on Health Care Service Provision at Home, (vii) the Guideline on Consultation Procedures Specified in the Medical Device Regulation and (viii) the Regulation on Health Claim Inspection.
The TİTCK also amended (i) the Regulation on Improvement and Evaluation of Quality in Health; (ii) the Regulation on Sale, Advertising and Promotion of Medical Devices; (iii) the Regulation on Marketing Authorization of Pharmaceuticals; (iv) the Regulation on Pharmacists and Pharmacies; (v) the Regulation on Pharmacies and Products Available in Pharmacies; and (vi) the Regulation on Procurement of Pharmaceuticals from Abroad, and announced the First Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products.
First Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products
On 10 May 2023, the TİTCK announced the results of its cosmetics sector market surveillance and inspection conducted in January, February and March 2023.
Of the 115 cosmetic products inspected by the TİTCK's Cosmetics Supervision Department, 96 were noncompliant and 4 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 414,050 (approximately USD 17,576).
Of the 8 type 1 and type 19 biocidal products inspected by the TİTCK's Cosmetics Supervision Department, 3 were unlicensed and 4 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 739,640 (approximately USD 31,397).
The 2023 first quarter results for cosmetic products are available here (in Turkish).
The type 1 and type 19 biocidal products' first quarter results for 2023 are available here (in Turkish).
What Do the Results Say?
The cosmetic products' safety results reveal that there has been a decrease in the number of inspected products and noncompliant products. In this regard, the total amount of administrative fines has decreased compared to the results for the fourth quarter of 2022.
The type 1 and type 19 biocidal products' safety results reveal that the number of inspected and unlicensed products has decreased, while the number of unsafe products has increased. Accordingly, there is also a significant increase in the total amount of administrative fines.
Regulation on Improvement and Evaluation of Quality in Health
On 26 May 2023, the Ministry of Health published the Regulation Amending the Regulation on the Improvement and Evaluation of Quality in Health. The main amendments introduced by the Regulation are as follows:
- Health institutions and organizations must conduct self-assessments within the scope of the Turkish Health Quality System. In addition, health institutions and organizations must submit self-assessment results and data on health quality indicators in their area of responsibility to the electronic system created by the Ministry of Health according to the announced schedule.
- Health institutions and organizations must establish a quality management unit that meets the requirements specified in the regulation in order to monitor, evaluate and coordinate quality activities carried out within the scope of quality standards in health. A full-time employee, preferably a manager, must be appointed as a quality management officer in the health institution and organization.
- The Ministry of Health shall carry out assessment and evaluation activities in health institutions and organizations in line with the quality standards in health. The Ministry of Health shall manage the assessment and evaluation process through the electronic system.
- Quality assessments shall be carried out in accordance with the Health Quality Standards Assessment, Evaluation and Rating system published by the General Directorate of Health Services.
- The Ministry of Health shall notify the results of the assessment and evaluation to the health institutions and organizations via the electronic system within 10 days at the latest following the completion of the activity. Health institutions and organizations can file an objection to the evaluation result within 3 working days at the latest from the notification of the evaluation result.
- Health institutions and organizations that obtain accreditation certificates within the framework of internationally accredited standards prepared by the Ministry of Health or its related/affiliated organizations are exempted from health quality assessments during the validity period of the certificate.
The Regulation is available here (in Turkish).
Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision
On 26 May 2023, the TİTCK published the Regulation on Technical Services for Medical Devices Used in the Scope of Health Service Provision. The regulation sets out the procedures and principles regarding the technical service activities to be carried out in order to eliminate the risks carried by medical devices and ensure their appropriate and safe use. The main developments introduced by the Regulation are as follows:
- Real and legal persons willing to perform technical service activities for medical devices must apply to the Authority and obtain a technical service activity certificate, a technical manager work certificate and a technical staff work certificate for the employees who will work within the company.
- The technical service activity certificate and technical staff work certificate must clearly state in which device groups and for which devices in these device groups technical service activities can be performed.
- The technical manager must be a full-time employee of the technical service tasked with fulfilling the responsibilities related to its services. The technical manager shall not work for more than one technical service.
- Technical staff is obliged to perform technical service activities in line with the scope of the work certificate and to issue a technical service report regarding these operations. In addition, the technical staff must carry the identity card with a photo issued by the technical service in their name, visible during their work at the health service provider. This identity card must include at least the name of the technical service, the name and surname of the technical staff, and the work certificate number.
- The technical service has the following authorizations:
- To provide basic technical training to the health service provider regarding the device within the scope of its authorization;
- To decide whether this process affects the safety and working performance of the device after the operation of the device in accordance with the manufacturer's instructions and procedures;
- To contact and inform the health service provider about the maintenance and repair processes of the devices; and
- To give an opinion on the deactivation of devices if requested by the health service provider.
- Modification, update and upgrade activities on the software and hardware of the devices and technical service activities within the scope of the warranty certificate must only be performed by the authorized technical service of the device. If the manufacturer or importer of the device deems it appropriate, modification, update and upgrade activities on the software and hardware of the device can also be performed by the private technical service.
The Regulation is available here (in Turkish).
Regulation on Sale, Advertising and Promotion of Medical Devices
On 26 May 2023, the TİTCK published the Regulation Amending the Regulation on Sale, Advertising and Promotion of Medical Devices. The main amendments introduced by the Regulation are as follows:
- For sales center authorization applications to be made after 1 January 2027, applicants manufacturing medical devices domestically must also submit a document showing that they have established and implemented a quality management system within the scope of the "EN ISO 13485 Quality Management System for Medical Devices" standard issued by a conformity assessment body accredited by an accreditation body authorized under Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance for the marketing of products.
- As of 1 January 2025, sales centers must provide or ensure the provision of basic technical training prior to the first use of the devices they manufacture or import, upon the written request of the relevant healthcare service provider, free of charge and for one time only.
- Sales centers can provide technical service training for the devices they manufacture or import in return for a fee for the lifetime of the device. In addition, sales centers must meet the written requests of the relevant health service provider for basic technical training within 3 months regarding the devices they manufacture or import.
- As of 1 January 2025, except for devices that do not require technical service, sales centers are required to issue a clear, simple and readable warranty certificate in an understandable language for the devices they manufacture or import. The duration of the warranty certificate must be at least 2 years or the value determined by the unit of measurement stipulated by the manufacturer of the device.
- In the implementation of administrative penalty decisions taken by the TİTCK under the Regulation or Law No. 7223, all sales centers that supply the product subject to the penalty to the market and keep it on the market are jointly and severally liable.
- Manufacturers or importers registered in the TİTCK's registration and information management system without a sales center authorization certificate must obtain the authorization certificate by 26 May 2024.
The Regulation is available here (in Turkish).
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