Medical Laboratory Regulation In Turkey

Medical Laboratory Regulation in Turkey means a new era within the jurisdiction of Turkey. The healthcare sector in Turkey undergoes constant evolution to meet international standards. Most recently, the Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Practices has been officially circulated in the Official Gazette dated 24 October 2025 and numbered 33057. Take a look at the relevant page here

This new legal framework brings significant advancements and stricter oversight mechanisms for medical laboratories and the broader healthcare sector. It is important to note that with this new regulation, the previous Regulation on Medical Laboratories (2024) and the Regulation on Genetic Disease Evaluation Centers (2020) have been repealed.

Introduction: Overview of the Medical Laboratory Regulation in Turkey

Regulation on Medical Laboratory Services and Advanced Technology Medical Laboratory Practices has been published in the Official Gazette dated 24 October 2025 and numbered 33057 (hereinafter as the Medical Laboratory Regulation in Turkey). Medical Laboratory Regulation in Turkey brings significant advancements in medical laboratories and the healthcare sector. The available article will present a brief outline of the potential features of the new Regulation.

It should be addressed at the outset that based on the circuit of the Medical Laboratory Regulation, The Regulation on Medical Laboratories published in the Official Gazette dated 4 June 2024 and numbered 32566, and the Regulation on Genetic Disease Evaluation Centers published in the Official Gazette dated 10 January 2020 and numbered 31004, have been repealed.

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Navigating these new technical regulations requires precise understanding and clear communication. Our team of lawyers in Turkey ensures that international investors and medical professionals can navigate the licensing process without language barriers.

Purpose and Scope of the Medical Laboratory Regulation in Turkey

Under Article 1, the primary objective of the Medical Laboratory Regulation in Turkey is to establish a comprehensive framework for the establishment, classification, licensing, and inspection of all medical laboratories. This scope extends to:

• Medical laboratories providing diagnostic and prognostic services.
• Genetic disease diagnosis and evaluation centers.
• Healthcare facilities where such services are integrated.

Establishing a medical laboratory requires a proper corporate structure. Visit our guide on Company Formation in Turkey for details.

Key Obligations for Investors and Healthcare Professionals from Medical Laboratory Regulation in Turkey

Medical Laboratory Regulation introduces a structured mechanism for supervision, imposing critical obligations that healthcare lawyers and professionals must navigate carefully.

Requirement for Prior Authorizationhe

For investors looking to enter the market, the process begins earlier than before. Obtaining prior authorization (ön izin) from the Ministry of Health is now mandatory for the establishment of any new standalone medical laboratory or center.

Mandatory Licensing and Operating Permits

Operating without a license is strictly prohibited. Pursuant to Article 7, a medical laboratory or center shall be opened only based on a license or an operating permit issued by the Ministry of Health.

Authorized Personnel and Qualifications

The Medical Laboratory Regulation in Turkey clearly defines who is authorized to establish these facilities. Standalone medical laboratories may be established by healthcare specialists who hold professional qualifications appropriate to the field. This specifically includes specialists in:

• Medical biochemistry
• Medical microbiology
• Medical pathology
• Infectious diseases and clinical microbiology
• Medical genetics and pediatric genetics.

Enhanced Physical Standards

To ensure quality and safety, the minimum physical criteria for all types of laboratories have been improved and detailed in accordance with Article 10 of the Regulation.

Establishing an advanced technology medical laboratory involves significant capital expenditure. Such investments often qualify for government support, including tax exemptions. To learn more about maximizing your financial returns, we recommend reviewing our guide on the Investment Incentive Regime in Turkey.

Conclusion: A New Era of Supervision through Medical Laboratory Regulation in Turkey

Pi Legal Consultancy is a full-service international law firm in Turkey, dedicated to guiding healthcare investors through complex regulatory landscapes and ensuring full compliance.

The 2025 Regulation demonstrates a clear intent by policymakers to fill gaps in the implementation of healthcare norms. By repealing older regulations and introducing stricter licensing and physical standards, a more comprehensive and reliable monitoring mechanism will be implemented for medical laboratories within the jurisdiction of Turkey.

For investors and medical professionals, compliance with these new norms is not optional but essential for sustainable operation.

As the hub of Turkey's healthcare and medical tourism sectors, Istanbul is a primary location for new laboratory investments. Our law firm in Istanbul provides on-the-ground support for licensing procedures with the Provincial Directorate of Health and local municipalities.

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.