Medical Device Registration in
Turkey
Ministry of Health
Regulatory Authority
Turkish Medicines and Medical Devices Agency (TMMDA)
Medical Device Regulation
Official Language
Turkish
Classification
Class I, IIa, IIb and III
Medical Device Registration in Turkey
- 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