Regulatory Authority
Turkish Medicines and Medical Devices Agency (TMMDA)
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016:2016 and ISO 9001
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.
