With a population that will soon surpass Germany and the 15th largest economy worldwide, Turkey represents a growing opportunity for medical device manufacturers. Although not a member of the European Union, the country is a candidate for EU membership and has adopted many European rules and regulations.
Many people do not realize that Turkey has transposed the EU Medical Devices Directive (MDD) and uses it as a basis for regulating medical devices. If you have CE Marking for your devices, you can capitalize on this to register your products in Turkey.
Getting started in Turkey
Prerequisites for device registration in Turkey include CE Marking, as well as evidence of conformity to EU Essential Requirements from either a Notified Body or self-declaration.
Because Turkish regulations emulate the MDD, the classification of medical devices and quality management system requirements are the same as European requirements. Turkey does require foreign manufacturers to appoint a local authorized representative based in Turkey.
All registration documents must be submitted to the Turkish Ministry of Health, which oversees medical device regulation in Turkey.
How we support medical device registration in Turkey
With offices in Istanbul, Emergo has the resources and expertise to register your devices with the Turkish Ministry of Health (Sağlık Bakanlığı). 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
- Translation and preparation of all registration documentation into 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