Medical Device Registration in Kyrgyzstan: Regulatory Process, Requirements, and Timelines

Regulatory Authority

Department of Medicines and Medical Devices under Ministry of Health of the Kyrgyz Republic

Link for Regulatory Authority

https://med.kg/

Local Regulation

Law “On Circulation of Medical Devices”

Classification of Medical Devices

• Class I
• Class IIa
• Class IIb
• Class III

Listing or Registration Requirements

The Applicant (Marketing Authorization Holder – MAH) of registration may be a person who manufactures or places an order for manufacture of medical devices and medical equipment. Non-resident manufacturer must designate the Authorized representative at the territory of Kyrgyzstan. 

The registration procedure is performed by the Department of pharmaceutical supply and medical equipment of the Ministry of Health of the Kyrgyz Republic.

1. Submission of the Application and registration dossier; 
2. Primary evaluation of the completeness of registration dossier documents within 10 business days; 
3. Analytical expert evaluation; 
4. Specialized expert evaluation within 30 business days; 
5. Inspection of the manufacturing site (if necessary); 
6. Decision on state registration of medical device; 
7. Issue of Registration Certificate within 10 business days; 
8. Placing the information in the State register of medical devices

Documents Required for Registration

• • Application for state registration of medical devices;
  • Registration dossier for medical devices;
  • Samples of medical devices in the quantity necessary for conducting research (tests) in accordance with the requirements of the standard for a medical device.
  • Specific reagents in the quantities necessary to conduct research (tests) in accordance with the requirements of the standard for a medical device.

Registration Timeline

90 business days

Registration Timeframe

As per Kyrgyz legislation, the national procedure for the state registration of a medical device or equipment should be completed within a maximum of 90 days from the application submission date, excluding the time for preparing responses to requests. 

Nevertheless, based on typical practices, the duration of the state registration process for a medical device in Kyrgyzstan may extend to approximately 4-5 months. This timeframe is subject to factors such as the completeness of provided materials, the extent of documentation, the number of requests from the competent authority, and other relevant considerations, excluding the time required for preparing responses to requests.

License Validity

5 years

Special Labelling Requirements

The registration dossier may be submitted in English, with the translation of some sections into Russian. The language for labelling and instructions for use (user manual) is Russian and/or Kyrgyz.

Import permit

Foreign-manufactured medical devices and equipment can enter the market of the Kyrgyz Republic following the completion of state registration. The application for registration is open for submission under both the “national” and “centralized” procedures of the Eurasian Economic Union (EAEU). 

Regardless of the chosen procedure, a non-resident manufacturer is required to appoint an Authorized Representative within the territory of Kyrgyzstan. The Authorized Representative, who must be a resident legal entity, assumes primary responsibility for the quality and safety of the medical device. 

Additionally, they are accountable for handling claims and serve as the primary point of contact between competent authorities and the manufacturer.

Who should make this Communication?

• Manufacturer
• Authorized representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk