MedStandard

Turkiye

Turkish Medicines and Medical Devices Agency (TMMDA)

Regulation on Medical Device: Published in the Official Gazette dated 02 June 2021 No.31499

 

Regulation on InVitro Diagnostic Medical Devices: Published in the Official Gazette dated 02 June 2021 No.31499

Закон о регулировании медицинских изделий

similar to the validity period of the CE

Turkish

2–3 months

country resident

A brief algorithm for registration of medical devices in Turkiye:

01

Determination of the classification of the device (I, IIa, IIb and III)

02

Preparation of Power of Attorney on the name of the company that will act as Authorized Representative

03

Collection of documents according to the approved list

04

In case of successful verification, the device will be published in the National Data Bank (TITUBB), which in turn will be used as proof of product registration

Final price and terms procedures will be calculated according to your request