The Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Practices (“Regulation”) was published in the Official Gazette dated 24 October 2025, and numbered 33057, and entered into force on the same date. With the enactment of this Regulation, the Regulation on Medical Laboratories and the Regulation on Genetic Diseases Evaluation Centers have been repealed.
The Regulation sets forth the procedures and principles governing the establishment, classification, licensing, operation, and inspection 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 the healthcare facilities where such services are provided. In addition, it regulates the principles regarding the definition and classification of treatment laboratories that perform various cellular, genetic, molecular, and regenerative applications for advanced therapeutic purposes, and research and development laboratories engaged in the study, storage, and development of human tissues, cells, or genetic material, as well as in the development of advanced technologies and medical devices.
The Regulation covers medical laboratories, genetic disease diagnosis and evaluation centers, treatment laboratories, and research and development laboratories belonging to the Ministry of Health, universities, public institutions and organizations, private legal entities, and natural people, as well as the personnel working in these facilities.
In the Regulation, a medical laboratory (“Medical Laboratory”) is defined as a “laboratory where biological materials are examined for the purposes of assessing human health, preventing and diagnosing diseases, monitoring treatment processes, and predicting prognosis, and where services are provided that include reporting results, interpreting them when necessary, and offering recommendations for further examinations”. Moreover, under the Regulation, medical laboratories are subject to certain sub-classifications based on the scope of services and activities they provide, and are also categorized according to their service and personnel capacities.
A genetic disease diagnosis and evaluation center (“Center”) is defined as “a facility where medical genetics laboratory services and outpatient clinic services are provided together, allowing for a comprehensive assessment of diagnosis and genetic counseling services related to genetic diseases”.
A- Preliminary Permit:
Pursuant to the Regulation, obtaining a preliminary permit from the Ministry of Health (“Ministry”) is a prerequisite for the establishment of a new Medical Laboratory or Center. Applicants whose preliminary permit applications are approved are issued a Preliminary Permit Certificate by the Ministry. If a license is not obtained within two years from the date the preliminary permit is granted, the certificate is cancelled. The preliminary permit certificate does not substitute for a license and cannot be transferred.
B- License and Operating Permit:
A Medical Laboratory or Center may be established only with a license or operating permit issued by the Ministry of Health. For Centers and Medical Laboratory units established within a healthcare facility, the relevant unit(s) must be registered on the facility’s license or operating permit.
The responsible manager must apply to the Provincial Health Directorate with the application form and documents included in the annex of the Regulation to request the issuance of a license or operating permit for the Medical Laboratory or Center. If there are no deficiencies in the file, an inspection and evaluation team of at least three members conducts an on-site inspection and assessment at the Medical Laboratory or Center based on the license or operating permit application. If no deficiencies are found during the inspection and evaluation, the inspection and evaluation form and the application file are sent to the Ministry. If the Ministry approves the license or operating permit application file, a unit/center manager certificate is issued for the relevant units/centers of the Medical Laboratory or Center along with the license or operating permit.
According to the Regulation, it is essential that only one medical laboratory be established in the same specialty within a healthcare facility. However, if services are provided in different campuses due to the physical space and functional structure of the healthcare facility’s main building, the responsible manager must submit a separate application for each Medical Laboratory, specifying its location, and the Ministry issues a separate operating permit for each Medical Laboratory within the healthcare facility.
In cases of adding or removing a unit, relocation, merger or transfer, change of address, change of name, or change of ownership, the license, operating permit, or permit of the Medical Laboratory or Center must be renewed. In such cases, an application must be submitted to the Provincial Health Directorate with the license or operating permit application form and documents prepared in accordance with the Regulation. If the Directorate determines that there are no deficiencies in the file, the application is forwarded to the Ministry within one month. If the application is approved, the license or operating permit is renewed.
For physical relocation or renovation works that do not require a change to the license, operating permit, or permit, approval must be obtained from the Provincial Health Directorate.
In the case of the transfer of a Medical Laboratory or Center, the facility may continue its operations under the former ownership and the responsibility of the responsible manager until a license is issued by the Ministry in the name of the new owner.
A Medical Laboratory or Center with a suspended license may be transferred only once during the suspension period.
C- Physical Criteria, Operating Principles, Personnel Standards, and Duties and Responsibilities of Personnel:
The Regulation sets out in detail the minimum physical criteria that Medical Laboratories must meet according to their classifications.
According to the Regulation, it is essential that work in the Medical Laboratory or Center be conducted using methods accepted by the Ministry, and the Regulation sets forth the operating principles to be followed.
Additionally, the Regulation sets out in detail the standards, duties, and responsibilities of the personnel working in the Medical Laboratory or Center.
D- Inspection, Suspension of Activities, and Revocation of License, Operating Permit, or Permit:
Medical Laboratories and Centers are inspected in accordance with the procedures and principles set forth in the Regulation on the Inspection of Private Healthcare Facilities, based on the criteria specified in the Medical Laboratory/Genetic Disease Diagnosis and Evaluation Centers Inspection, Inquiry, and Administrative Sanction Form included in the annex of the Regulation. If it is determined during inspections that the physical conditions of the Medical Laboratory or Center do not meet the requirements of the license or operating permit, its activities may be suspended for a maximum of six months. At the end of this period, if the Medical Laboratory or Center still fails to meet the license or operating permit requirements, the license or operating permit is revoked.
According to the Regulation, the activities of Medical Laboratories and Centers are suspended and their license, operating permit, or permit is revoked under the following circumstances:
- In relation to the tests performed: if critical nonconformities are identified through internal or external quality control evaluations that affect patient safety and cannot be corrected through corrective and preventive actions, the process of reporting results to patients for the relevant test or tests is suspended. If a Medical Laboratory or Center continues to report results to patients despite the suspension, its activities are suspended for six months. However, technical malfunctions originating from the quality control provider, data entry errors, unit or format errors, or other situations that do not directly affect patient results, if documented, are not considered within this scope.
- If a mandatory personnel assigned to a relevant unit of the Medical Laboratory or Center leaves their position, this must be reported to the Provincial Health Directorate within five business days. In the event of such a departure, a temporary assignment may be made for a maximum of three months with the Directorate’s approval, or services may be obtained from another licensed Medical Laboratory or Center to continue operations for up to three months.
If the mandatory personnel are not assigned within three months, the activities of the relevant unit of the Medical Laboratory or Center are suspended for six months. If operations do not resume by the end of this period, only the relevant unit of the Medical Laboratory is removed from the license or operating permit, and the license or operating permit of the remaining parts of the Medical Laboratory is renewed. However, if the Center or a Medical Laboratory providing services with a single unit fails to comply, the license or operating permit is revoked by the Ministry.
- In cases of renovations that require changes to the gross areas forming the basis of the license or operating permit in a Medical Laboratory, the activities of the relevant unit may be suspended for up to one year. If operations do not resume by the end of this period, only the relevant unit is removed from the license or operating permit, and the license or operating permit of the remaining parts of the Medical Laboratory is renewed. However, if the Medical Laboratory provides services with a single unit, the license or operating permit is revoked by the Ministry.
In a Center, if renovations require changes to the gross areas forming the basis of the license, the Center’s activities may be suspended for up to one year. If operations do not resume by the end of this period, the license is revoked by the Ministry.
- In cases of force majeure, such as natural disasters, widespread epidemics, or the declaration of partial or general mobilization, the activities of the Medical Laboratory or Center may be suspended by the Ministry for up to five years. If operations do not resume at the end of the suspension period, the license or operating permit of the Medical Laboratory or Center is revoked.
- If a Medical Laboratory or Center does not commence operations within one year from the issuance of its license or operating permit, the license or operating permit is revoked.
E- Prohibitions:
The Regulation specifies certain acts and behaviors that are prohibited as follows:
- Medical laboratory and genetic disease diagnosis and evaluation services cannot be provided without a license or operating permit. Individuals who do not have the authority to establish a Medical Laboratory or Center cannot open one.
- Responsibility for a unit or center cannot be delegated to individuals who do not have the authority.
- A Medical Laboratory or Center cannot operate using methods that are not in accordance with the proper procedures.
- A Medical Laboratory or Center cannot employ medical laboratory specialists in fields other than the specialty on which its license or operating permit is based.
- A Medical Laboratory or Center cannot engage in medical production, form partnerships with marketing companies, or create conflicts of interest without the Ministry’s permission. No activities other than those specified in the Regulation may be carried out in the Medical Laboratory or Center.
- Services cannot be provided at any location other than the address specified in the license or operating permit.
- Services cannot be provided using devices or tests other than those declared in the license or operating permit application.
- A Medical Laboratory or Center whose activities have been suspended or halted cannot provide services during this period.
- Tests aimed at identifying genetic diseases or determining whether an individual has a genetic predisposition or susceptibility to a disease cannot be performed in the Center except for medical necessity or medically oriented scientific research.
- In the Center, procedures are carried out only after the applicant has been informed and has given their informed explicit consent. Results cannot be disclosed to third parties without the individual's explicit consent.
F- Data Protection and Storage:
According to the Regulation, systems established for data management in the Medical Laboratory or Center must be operated in compliance with Law No. 6698 on the Protection of Personal Data.
Regarding the storage of physical and electronic reports and records in the Medical Laboratory or Center, processes and procedures are carried out in accordance with the legislation on the deletion, destruction, or anonymization of personal data.
In the Medical Laboratory or Center, it is mandatory to implement administrative and technical measures to prevent the alteration, deletion, or destruction of health data stored electronically, and to protect confidentiality against physical, magnetic, or electronic interference and potential misuse. Electronic data must be regularly backed up using a secure backup system. When electronic records are requested for inspection or other official purposes, all records must be consistent with previous outputs.
G- Ongoing Procedures:
Pursuant to the provisional article of the Regulation, applications submitted before the effective date of the Regulation are completed in accordance with the provisions of the Medical Laboratory Regulation and the Genetic Disease Diagnosis and Evaluation Centers Regulation, which have been repealed by this Regulation.
Furthermore, Medical Laboratories and Centers that were issued a license or operating permit before the Regulation came into effect continue their activities in their current state. However, no new units or divisions may be added to Medical Laboratories and Centers that do not meet the requirements specified in this Regulation.
You may access the mentioned Regulation via this link.