The 2024 Regulation on Medical Laboratories in Turkey was newly declared in the Official Gazette, as of June 4, 2024.
Relevant page of Official Gazette is available here: https://www.resmigazete.gov.tr/eskiler/2024/06/20240604-1.htm
The 2024 Regulation on Medical Laboratories abolishes the previous one, dated 9.10.2023. That change is very critical to navigate dynamics for medical professionals and healthcare lawyers.
Introduction
It is beyond doubt that medical laboratories play a crucial role in better promotion of healthcare services. This article will give a detailed outline about the new regulation applicable to Turkey healthcare system after June 2024.
Regarding healthcare system, see our practice areas titled on Healthcare
What are core legal healthcare instruments in Turkey?
It is significant to underline at the outset that health services are performed under the framework of the Law Numbered 1219 coming from 1928. Additionally, a new legislation on Health Services Law Numbered 3359 entered into force in 1987. Besides, particular services including genetic testing activities and medical device quality management systems are mainly governed by Regulations. Especially the Regulation on Genetic Diseases Evaluation Center and Regulation on Medical Laboratories are of utmost importance in constituting workable standards and principles for the subject matter.
For a comprehensive article on medical device quality management system, take a look at our article on Medical Device Quality Management System in Turkey
What is the aim of the 2024 Regulation on Medical Laboratories?
The purpose of this Regulation is to regulate the procedures and principles regarding the planning, licensing, opening, regulation of activities, classification, monitoring, inspection and termination of activities of medical laboratories and to ensure that they provide quality and efficient service.
What is the news from the 2024 Regulation on Medical Laboratories?
The first thing capturing our attention is the 2024 Regulation on Medical Laboratories begins with a long list of terminologies including biological material, operating license, medical laboratory license, national reference laboratory. The new Regulation is designed for fulfilling all previous gaps of 2013 Regulation from these aspects.
Besides, Article 7 clarifies the four main categories of medical laboratories that may be licensed for operating:
- Medical biochemistry laboratory,
- Medical microbiology laboratory,
- Medical pathology laboratory,
- Tissue typing laboratory.
In addition to that medical laboratories are classified into five categories in terms of service content and activities:
- Supervised medical laboratory,
- Comprehensive medical laboratory
- Regional laboratory,
- Reference authorized laboratory on a test basis.
- National reference laboratory.
Additionally, Article 9 stipulates the procedures in a detailed manner for application about license and activity permit [ruhsat in Turkish]. It is clearly underscored that a medical laboratory is only opened with a license and activity permit issued by the Ministry.
Additionally, the medical laboratory unit established within the health facility is recorded in the facility's license/activity permit as well.
Last but not least, physical conditions and working conditions of medical laboratories are thoroughly addressed in Article 12 and 13.
Medical Laboratories Planning under the 2024 Regulation on Medical Laboratories?
It is very important to note that according to the new Regulation, medical laboratories that need to operate are planned by the Ministry with the intention of ensuring quality and efficiency.
Conclusion
Having regard to all foregoing, this article already displayed that the 2024 Regulation on Medical Laboratories is intended to cope with previous handicaps arising from shortcomings of 2013 Regulation. All practitioners including medical lawyers are required to consider core potential solutions by the 2024 Regulation on Medical Laboratories. It is worth reiterating that working conditions and license requirements are formulated much more comprehensively in the the 2024 Regulation on Medical Laboratories.
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.