Turkey Medical Device Regulations

Agency
All medical devices are regulated by the General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device Services as part of the Ministry of Health.
Medical Device Definition
"Medical device" means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process
  • control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
 
Classification of Medical Device
International Classification Description Examples Risk Level
Class I (Non-sterile, Non-measuring) Simple with history of safe use Non sterile gloves Very Low
Class I (Sterile, measuring) Simple with history of safe use Simple surgical instruments, tongue depressor Low
Class IIa  relatively low risk to the human body Digestive catheters, infusion pumps, and powered wheelchairs Low - Moderate
Class IIb Relatively high risk to the human body Dialyzers, and orthopaedic implants High - Moderate
Class III Devices that may endanger the patient's life Coronary stents High
Premarket Approval Process
Class I (Non-sterile, Non-Measuring) Class I (Sterile, Measuring) Class IIa Class IIb Class III
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. Validity expires when CE Certificate expires
Post Market
Validity: Device registration expires when CE Certificate expires for all classes except for Class I non-sterile non-measuring. Validity for this class does not expire.
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