Amendments to Quality in Healthcare Sector and Medical Device Legislation
The Regulation Amending the Regulation on Enhancement and Evaluation of Quality in Healthcare (Regulation on Quality in Healthcare), the Regulation on Technical Maintenance Services for Medical Devices Used in Health Services (Regulation on Technical Maintenance Services for Medical Devices), the Regulation Amending the Regulation on Sale, Advertising and Promotion of Medical Devices (Regulation on Sale and Advertising of Medical Devices) are published in the Official Gazette dated 26.05.2023 and numbered 32202.
The amendments introduced by the Regulation on Quality in Healthcare are summarized below:
- Healthcare institutions and organizations shall record the results of their self-assessments within the scope of the Health Quality System (HQS) and data related to healthcare quality indicators in their areas of responsibility, in the electronic system established by the Ministry of Health.
- A quality management unit shall be established in healthcare institutions and organizations to monitor, evaluate and coordinate quality studies carried out within the scope of the HQS.
- The Regulation on Quality in Healthcare also includes details on quality measurement and evaluation in healthcare.
The amendments introduced by the Regulation on Technical Maintenance Services for Medical Devices:
- The qualifications, authorization and supervision of the technical services that will carry out the technical maintenance services of the medical devices used within the scope of healthcare services, the qualifications and training of the relevant personnel working in these technical services, and the obligations of the technical services and healthcare providers are regulated.
The amendments introduced by the Regulation on Sale and Advertising of Medical Devices:
- Sales centers shall provide basic technical training prior to the first use of the devices of which they are the manufacturers or importers, free of charge and for one time only, to the healthcare providers upon their written request.
- Sales centers are obliged to issue a warranty certificate for the devices of which they are the manufacturer or importer. The Regulation on the Sale and Advertising of Medical Devices also includes details on the content of the warranty certificate, the warranty period, the rights of the healthcare provider under the warranty certificate and the administrative fines to be imposed in case the sales centers violate their obligations.
- For the domestic manufacturers of medical device to be authorized as a sales center, a quality management system shall be established and implemented within the “EN ISO 13485 Quality Management System for Medical Devices” standard issued by a conformity assessment body accredited by an accreditation body authorized under Regulation (EC) No. 765/2008 of the European Parliament and of the Council.
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