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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