All medical equipment imports are subject to the approval of the Turkish Standards Institution (TSE). All products must be CE marked, except for custom made medical devices intended for clinical investigations. Foreign suppliers of medical equipment have to comply with ISO 9000 or equivalent standards and other EU regulations. The classification system is similar to that of the European Union.
Registration procedure involves appointing a local representative and registering the device with the local medical device database, TITUBB.
Our country specific (*) regulatory services in Turkey include:
Medical Device specific regulation strategy reports in Turkey, Medical Device Registration with the TSE and TITUBB, technical documents preparation, license holder and local Authorized Representative in Turkey, QSD registration and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
Please fill in the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Turkey!
(*) Turkish Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.
