Esin / Healthcare & Life Sciences - April 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published an announcement regarding European Union Regulations No. 2017/745 and 2017/746, an announcement on the List of Pharmaceuticals with Marketing Authorization, the Communiqué on Electronic Instruction Manuals of Medical Devices, and the Regulation on Health Services Provided Using Ionizing Radiation and Radionuclides.

The TİTCK also amended the Medical Device Regulation, the Regulation on Medical Device for In Vitro Diagnostic Purposes, the Private Hospitals Regulation, the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment, and the Communiqué on the Implementation Procedures and Principles of Intensive Care Services in Inpatient Health Facilities. In addition, a Draft Law on Amendments to the Law on Pharmaceuticals and Medicinal Preparations, Certain Laws and Decree Law No. 663 was submitted to the Grand National Assembly of Türkiye.

EU Regulations No. 2017/745 and 2017/746

On 20 March 2023, the TİTCK announced the entry into force of the Regulation of the European Parliament and the Council (“Regulation”) amending the transitional provisions of Regulations (EU) 2017/745 and (EU) 2017/746 on certain medical devices and in vitro diagnostic medical devices to reduce the risk of inability to supply medical devices.

In this regard, devices regulated in accordance with Directives 90/385/EEC and 93/42/EEC can be placed on the market or put into service until the following dates, provided that they fulfill the conditions set out in the Regulation:

• 31 December 2027 for Class III devices and Class IIb implantable devices, excluding sutures, staples, dental fillings, dental brackets, dental crowns, screws, wedges, plates, wires, pins, clips and connectors
• 31 December 2028 for Class IIb devices other than those mentioned above, Class IIa devices and Class I devices placed on the market in sterile condition or with a measuring function
• 31 December 2028 for devices for which the conformity assessment procedure under Directive 93/42/EEC does not require the involvement of a notified body, the declaration of conformity was issued before 26 May 2021, and the conformity assessment procedure under the EU Medical Devices Regulation requires the involvement of a notified body

In order for the Regulation to be applicable in Türkiye as of the effective date, studies are being carried out to make the necessary amendments to the transitional provisions of the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.

The Announcement is available here (in Turkish).

Draft Law on Amendments to the Law on Pharmaceuticals and Medicinal Preparations, Certain Laws and Decree Law No. 663

On 20 March 2023, a Draft Law on Amendments to the Law on Pharmaceuticals and Medicinal Preparations, Certain Laws and Decree Law No. 663 was submitted to the Turkish Grand National Assembly. The Draft Law proposes to add an additional article to the Law on Pharmacies and Stores Selling Poisonous and Potent Chemical Substances Used in Art and Agriculture, in line with the Law on Pharmacists and Pharmacies and the Regulation on Pharmacies and Products Stored in Pharmacies.

In this regard, pharmacies must notify the pharmaceutical tracking system of transactions such as purchase, sale, return, cancellation of sale, export, cancellation of export, transfer of goods, cancellation of transfer, and deactivation transactions of pharmaceuticals that have lost their qualifications due to expiration, theft, deterioration and similar reasons.

The Draft Law is available here (in Turkish).

Announcement on the List of Pharmaceuticals with Marketing Authorization

On 24 March 2023, the TİTCK published an announcement on the List of Pharmaceuticals with Marketing Authorization (“List”). In this regard, tabs named “Products for which the Marketing Authorization will be Suspended” and “Products for which the Packaging Size will be Cancelled” have been added to the List for products on the List whose barcode numbers are not available. For the products in these tabs, marketing authorization holders are required to submit barcode notifications to the TİTCK with their barcode approval letters until 24 April 2023.

The Announcement is available here (in Turkish).

Medical Device Regulation

On 2 April 2023, the TİTCK published the Regulation Amending the Medical Device Regulation. In this regard, the Medical Device Regulation (“Regulation”) has been amended in line with the Commission Implementing Regulation (EU) 2022/2347 dated 1 December 2022 and European Parliament and Council Regulation (EU) 2023/607 dated 15 March 2023, within the framework of harmonization with European Union legislation. The main amendments introduced by the Regulation are as follows:

• Certificates issued by authorized bodies in accordance with the repealed Medical Device Regulation and the Regulation on Active Implantable Medical Devices as of 25 May 2017 that have not been withdrawn and are still valid on 26 May 2021 will remain valid for the relevant risk class of devices after the expiry of the period specified in the certificate until the dates mentioned below:
• 31 December 2027 for Class III devices and Class IIb implantable devices, excluding sutures, staples, dental fillings, dental brackets, dental crowns, screws, wedges, plates, wires, pins, clips and connectors
• 31 December 2028 for Class IIb devices other than those mentioned above, Class IIa devices and Class I devices placed on the market in sterile condition or with a measuring function
• Certificates issued by authorized bodies in accordance with the repealed Regulation on Medical Devices and the Regulation on Active Implantable Medical Devices as of 25 May 2017 that are still valid on 26 May 2021 and expire before 20 March 2023 shall only be considered valid until the dates mentioned above if one of the following conditions is fulfilled:
• Before the expiry date of the certificate, a written agreement is signed between the manufacturer and the notified body in accordance with the Regulation for the conformity assessment of the device covered by the expired certificate or a device intended to replace this device.
• The TİTCK accepts an exception to the applicable conformity assessment procedure or requests the manufacturer to carry out the applicable conformity assessment procedure.
• Devices for which the conformity assessment procedure under the repealed Medical Device Regulation does not require the involvement of an authorized body, the declaration of conformity was issued before 26 May 2021, and the conformity assessment procedure under the Regulation requires the involvement of an authorized body, can be placed on the market or put into service until 31 December 2028.
• In order for the devices to be placed on the market or be put into service until the dates mentioned above, the following conditions must be fulfilled:
• Devices must continue to comply with the repealed Medical Device Regulation or the Active Implantable Medical Devices Regulation, as applicable.
• There must be no significant change in the design and intended use.
• The devices must not pose an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of public health protection.
• By 26 May 2024, the manufacturer shall implement a quality management system.
• Until 26 May 2024, the manufacturer or authorized representative must submit a formal application to the authorized body for conformity assessment of the device certified under the repealed Medical Device Regulation and the Regulation on Active Implantable Medical Devices or a device intended to replace this device.
• Until 26 September 2024, the notified body and the manufacturer must sign a written agreement for conformity assessment.
• Unless the manufacturer has agreed with the authorized body appointed by the TİTCK that it will carry out the surveillance, the authorized body issuing the certificate shall continue to be responsible for appropriate surveillance in respect of the applicable requirements for the devices it certifies.
• The authorized body signing the written agreement for conformity assessment will be responsible for surveillance of devices covered by the written agreement until 26 September 2024 at the latest. Where the written agreement covers a device intended to replace a device with a certificate issued in accordance with the repealed Medical Device Regulation or the Regulation on Active Implantable Medical Devices, surveillance will be carried out with respect to the device to be replaced.

The amendments entered into force on 20 March 2023.

The Regulation is available here (in Turkish).

Regulation on Medical Devices for In Vitro Diagnostic Purposes

On 2 April 2023, the TİTCK published the Regulation Amending the Regulation on Medical Device for In Vitro Diagnostic Purposes. In this regard, the Medical Devices for In Vitro Diagnostic Purposes Regulation (“Regulation”) has been amended in line with the European Parliament and Council Regulation (EU) 2022/112 dated 25 January 2022 and European Parliament and Council Regulation (EU) 2023/607 dated 15 March 2023, within the framework of harmonization with the European Union legislation. The main amendments introduced by the Regulation are as follows:

• Devices placed on the market before 26 May 2022 in accordance with the repealed Regulation on Medical Diagnostic Devices Used Outside the Body (In Vitro) as well as devices placed on the market as of 26 May 2022 can continue to be placed on the market or put into service.

The amendments entered into force on 20 March 2023.

The Regulation is available here (in Turkish).

Communiqué on Electronic Instruction Manuals of Medical Devices

On 6 April 2023, the TİTCK published the Communiqué on Electronic Instruction Manuals of Medical Devices, which repealed the Communiqué on Electronic Instruction Manuals of Medical Devices No. 29314 dated 2 April 2015. The main amendments introduced by the Communiqué are as follows:

• Manufacturers that provide users with instruction manuals electronically rather than in paper form are obliged to carry out a documented risk assessment covering the assessment of the compatibility of the different devices that can be used to view electronic instruction manuals with the website that displays them and the management of different versions of instruction manuals.
• For devices with a specific expiry date, other than implantable devices, manufacturers shall continue to provide instruction manuals electronically for 10 years from the date of placing the last device on the market and for at least two years from the expiry date of the last manufactured device.
• For implantable devices and devices without a specific expiry date, manufacturers shall continue to provide instruction manuals electronically to users for 15 years from the date of placing the last device on the market.
• Manufacturers must provide instruction manuals on their websites in Turkish and, where applicable, in the official language(s) of the European Union as determined by the member state of the European Union in which the device is provided to the user or patient.

The Communiqué is available here (in Turkish).

Private Hospitals Regulation

On 7 April 2023, the TİTCK published the Regulation Amending the Private Hospitals Regulation. The main amendments introduced by the Regulation are as follows:

• The Ministry of Health can suspend the activities of a private hospital for a maximum period of five years due to force majeure such as natural disasters, general epidemics, and partial or general mobilization.
• Private hospitals that obtained a license before the regulations on the number of beds entered into force or whose preliminary authorization and licensing procedures are in progress must be in compliance with the relevant regulations by 31 December 2024.
• Private hospitals that received preliminary authorization from the Ministry of Health before 1 January 2019 and failed to complete their licensing procedures at the end of the five-year licensing period will be granted a one-time extension, until 31 December 2028, to complete their licensing procedures.
• Doctors who had a clinic before 7 January 2023 will be exempt from the staffing limitations in at most two of the medical centers and/or private hospitals they will contract with. These doctors will continue to be exempt, provided that they close their clinics and reopen them in the same or a different city within three months.

The Regulation is available here (in Turkish).

Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment

On 7 April 2023, the TİTCK published the Regulation Amending the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment. The main amendments introduced by the Regulation are as follows:

• The Ministry of Health can suspend the activities of a private health institution for a maximum period of five years due to force majeure such as natural disasters, general epidemics, and partial or general mobilization.
• If there is no private health institution in the relevant branch in the city where the clinic doctor serves, the medical centers can conclude a contract by obtaining the opinion of the relevant commissions established by the Ministry of Health for planning purposes in the nearest possible province.
• Doctors who had a clinic before 7 January 2023 will be exempt from the staffing limitations in at most two of the medical centers and/or private hospitals they will contract with. These doctors will continue to be exempt, provided that they close their clinics and reopen them in the same or a different city within three months.
• The exemption rights of doctors who closed their clinics between 7 January 2023 and 7 April 2023 started on 7 April 2023.

The Regulation is available here (in Turkish).

Communiqué on the Implementation Procedures and Principles of Intensive Care Services in Inpatient Health Facilities

On 8 April 2023, the TİTCK published the Communiqué Amending the Communiqué on the Implementation Procedures and Principles of Intensive Care Services in Inpatient Healthcare Facilities. The main amendments introduced by the Communiqué are as follows:

• Private healthcare facilities are required to have at least four intensive care beds and a single-bed contact isolation room in their existing cardiovascular surgery intensive care wards, as well as at least three cardiovascular surgery specialist doctors by 31 December 2024 at the latest.
• Hospitals licensed before 21 August 2020, or whose preliminary authorization and licensing procedures are in progress, must arrange their neonatal intensive care units to have a maximum of 20 incubators in the same physical area by 31 December 2024 at the latest.
• Hospitals with adult intensive care and neonatal intensive care services suitable for distribution at more than one level that have been licensed before 21 August 2020 or whose preliminary authorization and licensing procedures are in progress must have at least two levels of intensive care services or beds approved in line with the plans of the Ministry of Health by 31 December 2024 at the latest.

The Communiqué is available here (in Turkish).

Regulation on Health Services Provided Using Ionizing Radiation and Radionuclides

The Regulation on Health Services Provided by Using Ionizing Radiation and Radionuclides was published on 13 April 2023 by Presidential Decree. The Regulation repealed the Regulation on Health Services Provided Using Ionizing Radiation and Radionuclides, which entered into force with the Presidential Decree No. 5530 and dated 25 April 2022. The main amendments introduced by the Regulation are as follows:

• Radiation oncology centers must comply with the following conditions:
• Radiation warning lights must be provided inside, outside and above the entrance door of the area where the ionizing radiation source is located, indicating whether or not radiation production is ongoing.
• In practices involving radioactive sources, necessary measures must be taken to ensure the safety and security of radioactive sources.
• A separate control room shall be provided for treatment devices, and the control unit shall not be located in the device room. There must be a sufficient number of closed circuit television systems to view the entire treatment room, including the diversion corridor, with no blind spots.
• In the area where the ionizing radiation source is located, it must be ensured that there is a circuit breaker system to stop the radiation production in case the door is opened during the treatment and that the radiation production can only be restarted from the control unit if the radiation production is stopped by opening the door.
• In the area where the ionizing radiation source is located, there must be an emergency stop button to switch the radiation production completely off in case of emergency.
• In practices involving radioactive sources, there must be automatic systems that return radioactive sources to a safe and secure position in the event of power outages and failures.
• The radiation areas of the centers in operation as of 13 April 2023 must be in compliance with the regulations by 13 April 2028.

The Regulation is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.

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