Health Practice Statement; is a legislative notification that provides, guides, pricing, regulates and enforces all other details of implementation of the state's health-related social policies. Social Security Institution Law No. 5502, Law No. 5510 and the "Regulation on the General Health Insurance Transactions Regulation".;
The Medical Device Sales, Advertisement and Promotion Regulation, which was published in the Official Gazette on May 5, 2014, and the companies that sell medical devices were obliged to take authorization documents to continue their activities. In order to obtain a certificate of authority, the companies are required to fulfill certain conditions.
For all businesses operating in the medical device sector and seeking authorization:
-The responsible manager and the personnel carrying out sales, promotion and clinical support activities must be trained and certified. One person can only be the responsible manager of a company.
In order to be able to work as responsible manager, sales and promotion staff and clinical support staff in the medical device business, it is necessary to take trainings in TCESİS, pass the exam successfully and must get the qualification certificate referring to Turkish Medicines And Medical Devices Agency.
The Product Tracking System Project aims to develop infrastructure in order to track medical devices and cosmetic products manufactured in our country or imported from other countries from the production line to places where they are sold and used.
The System (Product Tracking System) that has been developed is an e-government application which offers citizen-oriented services and has thousands of users
MEDICAL DEVICE REGULATION
On April 5, 2017 the EU adopted the new Medical Devices Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation will enter into force after a three-year transition period ending in spring 2020.