Three different regulations regarding the provision of healthcare services and medical devices were published in the Official Gazette dated May 26, 2023. The published regulations and their main subjects are outlined below.
• Regulation on Technical Service for Medical Devices Used within the Scope of Healthcare Service Provision
This Regulation regulates the procedures and principles related to technical service activities carried out to eliminate the risks associated with medical devices used within the scope of healthcare service provision and to ensure their proper and safe use.
In this regard, the regulation establishes provisions regarding the application processes that businesses, technical service providers, and healthcare service providers must complete to carry out technical service activities, as well as the authorization and obligations of technical services, technical personnel, and healthcare service providers, and the regulations on inspections and administrative sanctions.
• Regulation on Amendment to the Regulation on Improvement and Evaluation of Quality in Health
The main changes implemented by this Regulation are as follows:
- The qualifications of units and personnel responsible for quality work in provincial health directorates and healthcare institutions are defined.
- The minimum number of personnel to be assigned to quality management units is determined according to the number of beds.
- It is regulated that quality measurement and evaluation can be carried out by the Ministry of Health without prior notice to healthcare institutions.
- Healthcare institutions found to partially or fully fail to meet quality standards are required to prepare a quality improvement action plan.
- Institutions accredited by the Turkish Healthcare Quality and Accreditation Institute (TÜSKA) will be exempted from healthcare quality evaluations conducted by the Ministry of Health, and their quality scores will be accepted as 100 points.
- Healthcare institutions that score 95 or higher in healthcare quality evaluation will be announced, and they will be entitled to use the healthcare quality logo ("SKS") and receive plaques and/or certificates of achievement.
- Institutions accredited by the Turkish Healthcare Quality and Accreditation Institute (TÜSKA) will be exempted from healthcare quality evaluations conducted by the Ministry of Health, and their quality scores will be accepted as 100 points.
• Regulation on Amendment to the Regulation on Sales, Advertising, and Promotion of Medical Devices
The main changes implemented by this Regulation are as follows:
- Provisions regarding technical service activities are included in accordance with the provisions of the Regulation on Amendment to the Regulation on Improvement and Evaluation of Quality in Health.
- Regulations regarding production standards and quality management are introduced.
- Sellers of medical devices used within the scope of healthcare service provision are required to issue a warranty document, and regulations regarding the content, duration, and coverage of the warranty document are provided.
- Regulations regarding conference support for sales centers are included.
- The authorization and obligations of sales centers regarding technical training are regulated.
- Additionally, a list of devices that can be sold from channels other than sales centers is provided as an annex to the regulation.