Medical Device Registration in Turkey

Regulatory Authority

Turkish Medicines and Medical Devices Agency (TMMDA)

Classification

I, IIa, IIb, III

Quality system

ISO 13485:2016:2016 and ISO 9001

The information on this page is valid and current as of December 2015. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer

Medical Device Registration in Turkey

All Medical Devices must bear the CE marking and must be registered in the Turkish Ministry’s online database (TITUBB, Turkish Drug and Medical Device National Databank) in ordered to be marketed in Turkey.
Manufacturers without local presence in Turkey must appoint a Local Authorized Representative.
Thanks to agreements with the European Union, Medical Devices that obtained the CE marking benefit from a faster and more streamlined registration process.

Applicant

Local Authorized Representative.

Labelling and documentation language

Documentation and labelling must be provided in Turkish.

Useful information

Even if the registration procedure is carried out by the Local Authorized Representative, the owner of the registration is the manufacturer.