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.