Although Turkey is not a member of the European Union, the country is a candidate for EU membership and has adopted many European rules and regulations, including for medical devices. Because CE Marking is recognized in Turkey, most companies capitalize on their CE certification to register their medical device in Turkey.
The Turkish Ministry of Health oversees medical device regulation in Turkey. Prerequisites for registration include CE Marking as well as evidence of conformity to EU Essential Requirements from either a Notified Body or self-declaration. Classification of medical devices in Turkey is based on EU classification criteria. The requirements for a Turkish quality management system, as well as authorized representation are also harmonized with those in the EU.
With offices in Istanbul, Emergo has the resources and expertise to help you obtain medical device approval in Turkey. Naturally, we can also assist in obtaining CE Mark certification prior to your Turkey device registration.
How we support medical device registration in Turkey
Emergo can support all major components of your Turkish medical device certification. Our services include:
- Determining classification of your medical device or IVD according to the Turkish Medical Devices Directive
- Preparation of all application documents as well as proof of CE Marking and conformity to EU Essential Requirements
- Preparation of all labels and instructions in Turkish
- Submission of all registration documents through the Turkish Pharmaceutical and Medical Device National Databank (TITUBB)
- Independent authorized representation as your regulatory liaison in Turkey
- Managing Turkish customs audits of your device, if necessary