Medical Device Registration in
Ministry of Health
Medical Device Regulation
Class I, IIa, IIb and III
- 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.
- CE mark certification
- Technical File
- QMS certificate
- Declaration on Conformity
- Letter of Authorization
- Risk Management Plan
- Clinical Studies Report
Product Notification in the Product Tracking System (UTS) will take approximately 1 week.
Validity expires when CE Certificate expires