Recent Developments
The Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications has been published.
With the Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Applications (“Regulation”) being published in the Official Gazette dated 24 October 2025 and numbered 33057, the Regulation on Medical Laboratories and the Regulation on Genetic Diseases Evaluation Centers (“Repealed Regulations”) have been repealed.
The Regulation has been enacted to set out the procedures and principles governing the establishment, classification, licensing, operation and supervision of all medical laboratories and genetic disease diagnosis and evaluation centers that provide services for the protection of human health, prevention and diagnosis of diseases, monitoring of treatment processes, and determination of prognosis, as well as treatment and research and development (R&D) laboratories engaged in advanced technology medical laboratory practices.
The Regulation provides a comprehensive framework by encompassing not only medical laboratories previously governed under separate legislations, but also genetic disease diagnosis and evaluation centers, and treatment and R&D laboratories.
The Regulation is available here (in Turkish).
What Does the Regulation Introduce?
A. Principles regarding the establishment and activities of laboratories and genetic diseases diagnosis and evaluation centers
- For the establishment of a new standalone medical laboratory or genetic disease diagnosis and evaluation center, a preliminary permit must be obtained from the Ministry of Health (“Ministry”). Applicants whose preliminary permit applications are deemed appropriate by the Ministry shall be issued a preliminary permit certificate for the medical laboratory/center, as set forth in the annex of the Regulation. If a license is not obtained within two years from the date of issuance of the preliminary permit, the permit will be cancelled.
- Standalone medical laboratories/centers may only be relocated within the same province, provided that they comply with the planning criteria determined by the Ministry. Permission must be obtained from the Ministry when adding a unit to a medical laboratory or relocating a standalone medical laboratory/center.
- Provided that the planning criteria determined by the Ministry are met, a standalone medical laboratory/center may merge with another within the same province. The license of the merging medical laboratory/center will be cancelled and added to the license/operating permit of the healthcare facility with which it has merged.
B. Classification, physical criteria and operating principles
- Medical laboratories will provide services in the following areas, classified according to their service content and activities: (i) medical biochemistry laboratory, (ii) medical microbiology laboratory, (iii) medical pathology laboratory, (iv) medical genetics laboratory within the genetic diseases diagnosis and evaluation center, and (v) tissue typing laboratory.
- In terms of service and personnel capacity, medical laboratories will be classified as either a: (i) supervised medical laboratory, (ii) comprehensive medical laboratory, (iii) regional laboratory, (iv) test-based reference authorized laboratory, or (v) national reference laboratory.
- At least one examination room must be established in the center. The patient admission and waiting area may be shared with the healthcare facility.
- The medical laboratory/center must have the equipment and devices listed in the annex of the Regulation, depending on the relevant laboratory unit. However, if there is more than one medical laboratory licensed under the same private legal entity within the same province, it is not mandatory for each medical laboratory to physically possess all the listed devices, equipment and tools. The test-based reference authorized laboratory must have the equipment and devices required for the test(s) for which it is authorized.
- Medical laboratory units/centers consist of two main sections: technical and support areas.
I. Technical area
- For each of the medical biochemistry, medical microbiology and medical pathology laboratory units, at least 30 m² of technical area and at least 20 m² of support area must be provided.
- If there is more than one laboratory under the same private legal entity within the same province, it is not mandatory for all devices to be physically present in each medical laboratory, provided that tests not physically performed in the laboratory are carried out in the legal entity’s own central laboratory. In this case, the medical laboratory where the test will be performed and the test list must be notified to the Ministry.
- In the medical biochemistry laboratory, metabolism, toxicology, immunology, hematology, sero-immunology and molecular testing units may be established. New units may be established in line with technological developments, provided that the Ministry is notified.
- In medical microbiology laboratories where molecular tests are performed, pre-analytical, amplification and post-analytical areas must be physically separated and appropriately arranged to prevent contamination.
- If urine and stool tests are performed in the medical microbiology laboratory, they must be carried out in a separate area with appropriate ventilation or within the same technical area.
- For reproductive health-related tests and procedures, such as semen analysis and sperm preparation, to be performed by medical histology and embryology specialists within assisted reproductive treatment centers or in hospitals without such centers, a sperm collection room of appropriate size and privacy, and a connected technical area of at least 8 m², must be provided.
- The center’s central technical area will consist of two sections: a cytogenetics laboratory and a molecular genetics laboratory. The molecular genetics laboratory must be planned in accordance with a one-way workflow for pre-analytical, amplification and post-analytical procedures. Three separate rooms or areas must be created for these procedures, with a total area of at least 50 m². However, if fully automated and integrated devices capable of performing these processes are used, the requirement for physical separation will not apply, provided that the technical infrastructure prevents contamination and the integrated functionality of the device is documented with a technical report.
II. Support area
- In public health laboratories where biological material collection is not performed, it is not mandatory to have a biological material collection area.
- The support area must include a patient admission and waiting area, secretariat, restrooms, a room for the medical laboratory specialist and a staff lounge. The patient admission and waiting area and restrooms must not be located within the medical laboratory/center’s technical area.
- An appropriate area/room for the storage of chemical materials and an archive area/room must be established in the medical laboratory/center.
III. Operating principles
- In order to increase the reliability of diagnostic services in healthcare facilities, continuously improve the quality of analytical processes and thereby ensure patient safety, internal quality control and external quality assessment activities will be carried out in accordance with the periods and operating principles determined by the Ministry.
C. Personnel standards and duties and responsibilities of personnel
- Medical laboratories/centers must employ at least one medical laboratory specialist appropriate to the laboratory unit and specialty.
- In tissue typing laboratories, in order to ensure continuity of service, it is mandatory to appoint two medical laboratory specialists, one of whom will act as the unit supervisor. These individuals must be physicians.
- The medical laboratory specialist working as the unit/center supervisor must work on a full-time basis. Outside of working hours, the unit/center supervisor may work in another medical laboratory/center within the same province, provided that they do not assume another unit/center supervisor role. Other medical laboratory specialists may work in another medical laboratory/center within the same province outside of working hours. Compliance with the Regulation must be ensured by 1 June 2026.
- For each medical laboratory unit/center, at least seven medical laboratory and pathology technicians or medical laboratory technologists must be employed in national reference laboratories and regional laboratories, at least three must be employed in comprehensive medical laboratories providing training services, at least one must be employed in comprehensive medical laboratories, and at least one must be employed in supervised medical laboratories.
- The number of support service personnel to be employed in the medical laboratory/center will be determined by the unit/center supervisor.
- In the center, individuals who have completed undergraduate education in molecular biology and genetics, or a doctorate in one of the main branches of molecular biology and genetics, medical genetics, medical biology and genetics, or medical biology, and who can document at least one year of experience in a licensed center, may work as technical personnel.
- In each medical laboratory unit/center, a person who meets the requirements for being a supervisor will be appointed as the unit/center supervisor.
- The unit/center supervisor will assign duties for the work and procedures under their responsibility in the relevant medical laboratory/center.
- The regional laboratory supervisor will determine the personnel, device and infrastructure capacity of the laboratory according to test requests from healthcare facilities, and they will notify the administration, organize the transfer of biological materials and the delivery of results to the relevant healthcare facilities, and coordinate the supply processes related to the tests.
- Medical laboratory and pathology technicians and medical laboratory technologists will perform analyses under the responsibility of the unit/center supervisor and/or medical laboratory specialist.
- All personnel working in the medical laboratory/center are required to wear identification cards containing a QR code compatible with the Ministry’s electronic system.
- Pursuant to Law No. 1219 on the Practice of Medicine and Its Branches (“Law No. 1219”), medical histology and embryology specialists may carry out semen analysis, sperm washing, morphology evaluation, staining and related andrology tests, participate in the evaluation of results, and prepare the necessary reports, provided that they work in the area for which the medical laboratory is licensed or has an operating permit.
- Pursuant to the Law No. 1219, oral pathology specialists may work in medical pathology laboratories, limited to performing and reporting morphological and cytological examinations of biopsy materials within their field of expertise, as defined in the core training curriculum accepted by the Medical Specialization Board.
D. Treatment laboratory and R&D laboratory
- The research, development, production, clinical application, quality control and licensing processes of advanced therapy products and methods will be subject to the relevant legislation.
- Activities carried out in R&D laboratories, such as biobanking, tissue engineering, translational medicine, genomics and bioinformatics studies, as well as pharmaceutical and toxicological analyses and medical device development, will be conducted in accordance with the ethical, financial and quality assurance rules stipulated in the relevant legislation.
- Licensing, authorization, inspection, suspension of activities and cancellation procedures for treatment and R&D laboratories will be carried out in accordance with the provisions of the relevant legislation.
- Treatment and R&D laboratories may collaborate with medical laboratories/centers. During such collaboration, analyses, use of space, quality management and data integration will be carried out in cooperation with medical laboratory specialists.
- Treatment laboratories will be classified according to their field of activity, such as gene therapy, cell therapy or RNA/DNA-based therapy. These laboratories will be planned and licensed in accordance with the relevant legislation and will comply with the technical, ethical and quality standards determined by the Ministry. The same laboratory may operate in more than one subcategory.
- In R&D laboratories, experimental and analytical studies will be conducted for the development of new products, methods, technologies or models, as well as for the improvement of existing practices. These laboratories will carry out planning and licensing processes in accordance with the relevant legislation. The transition of developed methods and products to clinical stages will be subject to the licensing and authorization processes stipulated in the relevant legislation.
- During the application process, R&D laboratories will be classified into subgroups as: (i) medical device and technology development laboratories, (ii) translational R&D laboratories, (iii) tissue engineering laboratories, (iv) genetic disease risk modeling and bioinformatics laboratories, and (v) pharmaceutical and toxicology R&D laboratories.
- If R&D laboratories operate in an area different from their declared R&D activities, permission must be obtained from the Ministry.
- In R&D laboratories, matters related to patents, intellectual property, data confidentiality and the protection of ethical principles will be carried out in accordance with the relevant legislation. For research or studies involving the use of humans or animals, or biological materials obtained from the human body, as well as research conducted using in vitro diagnostic medical devices and biological products, the approval, registration and authorization processes stipulated by national ethics committees and the relevant Ministries must be followed.
- In R&D laboratories, activities related to microbiome banking and research laboratories, culture collections and pathogen banks will be carried out in accordance with the working procedures and principles determined by the Ministry.
E. Prohibitions and administrative sanctions
- In cases of serious violations that directly threaten patient safety or the provision of services in units without an operating permit, administrative sanctions will be imposed directly without a warning process.
- Regarding the tests performed, if critical nonconformities affecting patient safety are detected as a result of internal quality control or external quality assessment and cannot be remedied by corrective, preventative actions, the process of delivering results to patients for the relevant test(s) will be suspended. However, technical malfunctions originating from the quality control provider, data entry errors, or unit or format errors that do not directly affect patient results will not be considered within this scope, provided that they are documented. If a medical laboratory/center continues to deliver results to patients despite the suspension, its activities will be suspended for six months.
- In the event of the departure of mandatory personnel assigned to the relevant unit of the medical laboratory or center (notifying the directorate as required), temporary assignment may be made for a maximum of three months with the approval of the directorate, or services may be continued for a maximum of three months through service procurement from another licensed medical laboratory/center.
- In cases of modifications in the medical laboratory or center that require changes to the gross areas forming the basis of the license or operating permit, the activities of the relevant unit of the medical laboratory may be suspended for up to one year.
- In the event of the leave, illness or departure of the minimum number of medical laboratory specialists in the center, the center may continue its activities with a non-staff temporary medical laboratory specialist for up to three months. If a staff medical laboratory specialist is not appointed at the end of three months, the center’s license/operating permit will be cancelled.
- If a medical laboratory/center continues its activities partially or fully, despite being temporarily suspended, its activities will be completely suspended for twice original period. If the medical laboratory/center continues its activities, despite being suspended for twice the original period, its license/operating permit will be cancelled by the Ministry.
- The use of tests and kits produced solely for research purposes is prohibited if in-laboratory validation has not been performed in accordance with national or international guidelines, and validation documentation is not provided during inspections.
- External quality control programs and program providers without a TS EN ISO/IEC 17043 accreditation certificate for the tests to be performed may be accepted if they are evaluated by the commission and approved by the Ministry.
F. Information systems, data protection and retention
- Laboratory information systems must comply with the technical standards and data formats announced by the Ministry regarding data transfer and integration processes. The system architecture and software infrastructure must be structured to meet these technical requirements.
- Medical laboratories/centers whose activities have ended or been terminated must deliver their written records and physical archive materials, as well as slides and blocks in medical pathology laboratories whose retention period has not expired, to the directorate in accordance with the relevant legislation. Medical records and patient result data kept in electronic form must be transferred in an integrated manner to the Ministry’s database via data transfer systems defined by the Ministry.
G. Service procurement
- Standalone medical laboratories/centers may procure services from another medical laboratory/center holding a license/operating permit issued by the Ministry for tests in their licensed unit(s) and for specialty tests not available within their own structure, provided that a contract is concluded.
- If medical laboratory services are provided through service procurement, a service procurement contract/protocol must be executed between the healthcare facility receiving the service and the healthcare facility providing the service. The contract/protocol must clearly specify the parties responsible for all stages of the total testing process.
H. Transitional provisions
- Applications made before the entry into force of the Regulation will be completed in accordance with the Repealed Regulations. The validity of old licenses and permits will be preserved, and existing licensed laboratories and centers may continue their activities, but new units may not be added to locations that do not meet the new requirements.
- Persons serving as responsible personnel in tissue typing laboratories at the time the Regulation enters into force may continue in their positions. In addition, physicians who have completed a doctorate or doctoral training in the relevant fields will retain the right to serve as responsible personnel in genetic centers if they document certain conditions.
Conclusion
The Regulation introduces important innovations across various areas, including the licensing and authorization processes of medical laboratory services and advanced technology medical laboratories, personnel standards and the duties and responsibilities of personnel, inspection mechanisms, information systems, and the protection and retention of data. It is essential that all stakeholders in the sector closely follow the new obligations and implementation principles introduced by the Regulation, as well as the guidelines and directives to be issued by the Ministry of Health and other relevant institutions in the coming period.
