Medical Device Registration in Turkey

Ministry of Health

Ministry of Health

Regulatory Authority

Turkish Medicines and Medical Devices Agency (TMMDA)

Medical Device Regulation

Medical Device Regulation

Official Language

Turkish

Classification

Class I, IIa, IIb and III

Registration Process

• Determine the Device Classification
• Appoint Turkish Registrant to submit registration application.
• Submit translated EU Declaration of Conformity (DoC) and translated and notarized CE Certificate (translated and notarized).
• Submit product information (i.e. device labeling, Instructions for Use (in Turkish), product barcodes, Global Medical Device Nomenclature (GMDN) code, United Nations Standard Products and Services Code (UNSPSC)) for review.
• If accepted, the device will be published in the National Data Bank (TITUBB) which will be used as proof of device registration.

Documents Required

• CE mark certification
• Technical File
• QMS certificate
• Declaration on Conformity
• Letter of Authorization
• Risk Management Plan
• Clinical Studies Report

Applicable QMS

ISO 13485

Registration Timeline

Product Notification in the Product Tracking System (UTS) will take approximately 1 week.

Authorized Representative

Yes

License Validity

Validity expires when CE Certificate expires