Our Knowledge of the Turkish Medical Device Market ensures that we can support you with an efficient
regulatory strategy for your medical device when entering the Turkish market.
With a population of 83 million, the number of active hospitals in Turkey exceeded 1500, 571 of
them were private hospitals, the total bed capacity in Turkish hospitals exceeds 200,000, Turkey
is a growing market for medical technologies and healthcare services.
The Ministry of Health (MoH) is responsible for planning and implementing the country’s healthcare policy and is also the largest healthcare service provider. Turkey adopted the EU’s CE Mark and medical device regulation, which require that medical devices bear the CE Mark in order to enter the Turkish market. A Company ( Manufacturer or its representative) must register products in the National Data Bank (UTS) that tracks all medical equipment to be marketed in Turkey. This registration has four major steps:
1. Company Registration
Manufacturer (based in Turkey) or its representative should be registered with the UTS. Companies should hold Medical Device Sales Center Authorization Certificate. This process takes approx. 1 week.
2. Document Registration
After the company is approved, product documents (CE and ISO 13485 certificates, DoC, IFU) are entered into system. Document approval takes approx. 1 week.
3 . Product Registration
After the documents are approved, products should be registered with the UTS. Additional information about products and documents are needed. Approval takes approx. 2 weeks.
4. Reimbursement Code Application (optional)
Reimbursement code application should be made after the products are approved. SGK opens calls for applications every three months. The approval period is about 4 months.
With our expertise and consultancy, you will be sure that your product is registered to Turkish Databank of Medical Device. We help you chosing the most suitable reimbursement code for your product and define the most suitable sales strategy together with you.
We act as a team.
To learn more about what we can do for you when launching your product in to Turkish Market , drop us an E-mail