Medical devices and medical equipment of foreign manufacture may be imported and placed on the market of the Kyrgyz Republic after state registration. The Application for registration may be submitted both under the “national” and under the “centralized” procedure of the EAEU.

The procedure for national registration is described below. The description of the procedure for registration of medical devices within the framework of the Eurasian Economic Union can be found by the following link. 

A non-resident manufacturer must designate the Authorized representative in the territory of Kyrgyzstan, regardless of the selected procedure. The Authorized representative of the manufacturer must be a resident legal entity that bears primary responsibility for the quality and safety of the medical device, as well as responsible for claims and acts as the point of contact between competent authorities and the manufacturer. 

The national procedure for state registration

The national procedure for registration is established by the Resolution of the Government of the Kyrgyz Republic No. 311 “About some questions related to registration of medical devices” dated July 5, 2018.

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

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

The stages of the registration procedure:

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; 

During the expert evaluation, the competent authority may ask questions or make the observations (deficiency letters) to which the Applicant must respond within a term not exceeding 60 calendar days. 

Registration certificate for the medical device is issued without expiry. 

Inspection 

Inspection of manufacturing site can be required in the following cases:

• First registration of medical devices released from suggested manufacturing site; 
• Manufacturing site of a medical device previously registered in the Kyrgyz Republic was not inspected before; 
• Assessment of the registration materials for the reproduced medical device; 
• In cases related to quality control: if analytical expert evaluation is impossible (not reasonable) due to the high cost of medical device samples, the impossibility of meeting the transportation and (or) storage conditions of the specified samples, the lack of special equipment and consumables. In this case technical tests (studies) are carried out in the presence of representatives of the authorized body in the quality control laboratory of the medical device manufacturer or in the contract laboratory used by the manufacturer.
• If submitted documentation does not allow to make necessary decisions regarding safety, quality and productivity of the medical device. 

Changes and variations 

The manufacturer is obliged to initiate the variations procedure within two months from the date of implementation of the changes. 

There is no “notification” procedures. Any changes require assessment and approval by the competent authority. 

The variations procedure takes up to 60 business days. Registration certificate is amended as a result of the procedure. 

Medical devices placed on the market of Kyrgyzstan in previously approved package and/or instruction for use are allowed for sale until the expiration date.

Renewal of registration 

The re-registration procedure is not applicable.

Cratia provides professional services of state registration of medical devices in Kyrgyzstan. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.