The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published the Announcement on Operations Under the Regulation on Testing, Control and Calibration of Medical Devices and the Regulation on Market Control of Pharmaceuticals and Foods for Special Medical Purposes.
The TİTCK also amended the Guideline on Import Applications and Marketing Authorization.
Announcement on Operations Under the Regulation on Testing, Control and Calibration of Medical Devices
On 4 November 2024, the TİTCK published the Announcement on Operations Under the Regulation on Testing, Control and Calibration of Medical Devices. As stated in the TİTCK's previous announcement, within the scope of the obligation for testing, control and calibration of medical devices to be carried out by institutions authorized by the TİTCK pursuant to the Regulation on Testing, Control and Calibration of Medical Devices, the implementation date of the obligation to be authorized by the TİTCK for medical devices of the health service providers in Ankara, İzmir, İstanbul and Tekirdağ provinces, has been postponed from 1 January 2025 to 1 July 2025. In-scope medical devices include the following: i) fetal hand doppler devices in the Ultrasound/USG/ Doppler/ECO branch type in the Ultrasound — Doppler Imaging Systems authorization group; ii) EEG, ECG, Holter, Pulse Meter / SPO2 / SPCO medical monitor branch types in the Physiological Signal Monitoring Systems authorization group; iii) operating table, aspirator, infusion pump, cot, incubator, perfusion pump, sphygmomanometer branch types in the Flow, Weight, Length, Volume, Temperature, Pressure, Speed authorization group; and iv) those in anesthesia, bipap, cpap, spirometer, ventilator branch types in the Respiratory Systems authorization group.
Accordingly, as of 1 July 2025, all health service providers of public and private legal entities and real persons serving in İzmir, İstanbul and Tekirdağ are required to receive services from institutions authorized under the Regulation on Testing, Control and Calibration of Medical Devices in the testing, control and calibration activities to be carried out on the aforementioned medical devices.
The Announcement is available here (in Turkish).
Guideline on Import Applications and Marketing Authorization
On 8 November 2024, the TİTCK updated the Guideline on Import Applications and Marketing Authorization. In this regard, to obtain the Approval for Raw Material Control Certificate, which is one of the approval documents issued for the products listed in Annex1/A or Annex-1/B to the Communiqué on Import Control of Certain Products Controlled by the Ministry of Health (Product Safety and Inspection: 2024/20) ("Communiqué") and the products that can be imported, as well as the Customs Exemption Certificate for the import of starting or intermediate materials used in the production of raw materials in the composition of the relevant products, the production site permission documents of the production facilities of the products where the raw material must be submitted. Moreover, if the pharmaceutical dosing form of the products is not included in the production operations section of the production site authorization certificate, an application must be submitted to the TİTCK to add the relevant pharmaceutical dosage form to the production site authorization certificate, and the application petition and tracking number must be submitted.
The Guideline is available here (in Turkish), and Annexes of the Communiqué are available here (in Turkish).
Regulation on Market Control of Pharmaceuticals and Foods for Special Medical Purposes
On 21 November 2024, the TİTCK published the Regulation on Market Control of Pharmaceuticals and Foods for Special Medical Purposes and repealed the Regulation on Market Control of Pharmaceuticals dated 1 June 2023. The main amendments introduced by the Regulation are as follows:
- A Market Control Planning Board ("Board") will be established with a total of nine members who will make scientific and administrative evaluations to ensure that pharmaceuticals and foods for special purposes licensed or authorized by the TİTCK comply with the regulatory requirements.
- The risk parameters set by the Board for the products and
active substances to be included in the market control program by
the TİTCK for the compliance of these pharmaceuticals and
foods for special medical purposes with the required requirements
are as follows:
- Whether there are national or international notifications or pharmacovigilance data received by the TİTCK regarding the efficacy, safety and quality of the product
- The level of compliance of the production site with Good Manufacturing Practices
- Whether a withdrawal was made for the product before, and if so, the class and level of the withdrawal
- Withdrawal data in countries where the product is licensed
- Recommendations after inspections carried out by inspectors
- Notifications regarding the licensing and procedures related to the product
- Whether the product was previously included in the market control program
- Pharmaceutical form of the product and whether it is a sterile product
- Whether the product is a biological/biotechnological product
- Market and usage data of the country where the product is licensed, if any.
- As a result of the assessment made in line with the abovementioned risk parameters, a blocking decision of relevant products from supplied or placed on the market may be given through the Medicine Tracking System.
- Pharmaceuticals and foods for special medical purposes received by the National Laboratory of Control will be analyzed in accordance with their intended use and potential impact, which may directly or indirectly affect the quality, efficacy and safety assessment.
- In the analyses performed by the National Laboratory of Control, internationally accepted pharmacopoeia methods, in-house validated analysis methods of the product and analysis methods included in internationally accepted scientific guidelines or scientific publications will be applied
- In the case of failure to fulfill the requirements of the withdrawal decision, administrative fines from TRY 69,353 (approx. USD 1,984) to TRY 693,530 (approx. USD 19,843) may be imposed in accordance with Product Safety and Technical Regulations Law No. 7223.
- If the production site permit holder and the marketing authorization/permit holder do not submit the necessary analysis methods, active substance specifications and information on storage and transport conditions of the product to the National Laboratory of Control in cases where the product is included in the market control program, a blocking decision may be given for the relevant product and/or active substances to be supplied or placed on the market through the Medicine Tracking System (tr. İlaç Takip Sistemi).
The Regulation is available here (in Turkish).
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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
