Our Works

Health Practice Statement
11.10.2018 Read More
Health Practice Statement

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".;

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TCESİS
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TCESİS

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.
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Product Tracking System (ÜTS)
11.10.2018 Read More
Product Tracking System (ÜTS)

About Project

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

Project Goals
• To develop a national and original Product Tracking and Monitoring Model
• To provide an infrastructure whereby medical devices and cosmetic products are recorded compliant with GS1 standarts to enable their monitoring
• To contribute to ensuring patient safety and protecting public health
• To create an infrastructure to ensure that surveillance mechanisms are conducted in efficient and effective manner
• To create an infrastructure to enable Medicines and Medical Devices Agency of Turkey to swiftly respond to risks that may result from the use of medical devices and cosmetic products
• To contribute to preventing the unregistered economy through the tracking of medical devices and cosmetic products


MEDICAL DEVICE REGULATION
11.10.2018 Read More
MEDICAL DEVICE REGULATION

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.