Medical device and IVD manufacturers planning to sell their products in Turkey must appoint a Turkey Authorized Representative if they have no local presence in the country.
Your Turkish Authorized Representative is a regulatory liaison who manages your registration process and interacts with the Turkish Ministry of Health on your behalf. Turkey’s medical device and IVD regulatory system is harmonized Europe, and you may use your EU Authorized Representative as your Turkey Authorized Representative if they have a licensed office in Turkey.
Emergo Group has offices in Istanbul, and can meet all your Authorized Representative requirements in order to bring your medical device or IVD to market in Turkey.
Let Emergo Group act as your Authorized Representative in Turkey
As your Authorized Representative in Turkey, Emergo Group will ensure that your medical device registration is as successful as possible. Our representation service includes:
- Compiling all documentation required for Turkish registration, including CE Mark certificates, sample labels and instructions for use, and Global Medical Device Nomenclature (GMDN) codes
- Submitting all application materials online to the Turkish Ministry of Health Pharmaceutical and Medical Device National Databank (TITUBB)
- Manage all communications with Turkish regulators on your behalf
- Support your post-market obligations once your device is approved
Why choose Emergo Group to as your Authorized Representative in Turkey?
- We provide Authorized Representative support for hundreds of medical device and IVD companies worldwide
- We have been serving medical device and IVD markets since 1997
- We are an ISO 13485 certified firm
- We provide you with secure online access to all your documentation necessary for registration in Turkey
- Our offices are based in Istanbul, the commercial capital of Turkey
- With offices in Europe, North and South America, Asia, Australia and the Middle East, we can support your registration efficiently regardless of your time zone
Please contact us to learn more about our Turkey Authorized Representation service.