Registration of medical devices in Kyrgyzstan

Following recent amendments to the Eurasian Economic Union (EAEU) regulations on registration of medical devices, the transitional period, during which applicants may submit medical device registration dossiers either under the EAEU unified procedure or in accordance with the national legislation of individual member states, has been extended until December 31, 2027.

Choosing the national registration pathway in Kyrgyzstan also offers several advantages. Notably, applicants are not required to conduct local studies within the EAEU territory that are often both expensive and time-consuming. Instead, existing clinical data from the applicant’s side may be accepted, significantly reducing both the time and cost of the registration process. Upon successful completion of the registration procedure manufacturers are granted Registration Certificates with an unlimited validity period.

Issues associated with the state registration of medical devices and equipment in Kyrgyzstan are regulated by the Ministry of Health of the Kyrgyz Republic. Medical devices and equipment are allowed for use in Kyrgyzstan only after state registration and their introducing to the state register.

Registration procedure

The national registration procedure is performed by the Department of Medicinal Products and Medical Devices under the Ministry of Health of the Kyrgyz Republic.

There are 2 options for state registration of medical devices and medical equipment in Kyrgyzstan:

1) National state registration procedure*
*Technical tests, biological evaluation studies, clinical and clinical-laboratory trials of a medical device/medical equipment must be conducted prior to the registration procedure and submitted to the authorized body together with the application as part of the registration dossier.

2) Simplified procedure of state registration** of medical device/medical equipment in case of providing a valid document confirming registration as a medical device in countries of the EU, Australia, Switzerland, Norway, Canada, Japan, UK or USA.
**The number of required documents is less than for the full procedure and submission of reports on technical tests, biological evaluation studies, clinical and clinical-laboratory trials of a medical device/medical equipment is not required.

According to the demands of this procedure the following stages are required:

• Submission of the application form and registration dossier on a medical device or medical equipment;
• Preliminary examination of the registration dossier;
• Payment of the state fee for the registration procedure;
• Examination of the safety, efficacy and quality of medical devices that includes a full assessment of the compliance of provided documents and reports with requirements;
• Inspection of the manufacturing site*** (if required);
• Issuance of the conclusion on safety, quality and efficacy of a medical device or equipment;
• Registration of medical devices or equipment, introduction of data to the state register and issuance of the Registration Certificate.

Pay attention

According to the demands of the Kyrgyz Republic a foreign manufacturer must have its authorized representative with registered office in Kyrgyzstan and provide this information in the registration dossier. In case of absence of such a representative from your side we will be pleased to provide the service on acting as the authorized representative of the manufacturer in the Kyrgyz Republic.

What is required for registration

In order to register a medical device or equipment, the following should be provided to the Department of Medical Products and Medical Devices under the Ministry of Health of the Kyrgyz Republic:

• 1) Application form with the legalized Power of Attorney from the manufacturer to the representative in respect of Regulatory Affairs actions;
• 2) Registration dossier according to the current requirements of the Kyrgyz Republic;

Manufacturing site inspection

Regarding the manufacturing site inspection as part of the state registration procedure, the authorized body carries it out in the following cases:

• the medical device belongs to 2a (sterile), 2b and 3 classes of potential risk of use;
• the medical device is manufactured in the Kyrgyz Republic.

The term for organization and conduction of the inspection is not included in the total period of examination and should not exceed more than 90 calendar days.

*** Inspection is not required in case of providing a valid document confirming registration as a medical device in the countries of the EU, Australia, Switzerland, Norway, Canada, Japan, UK or USA.

Timeframe

According to the Kyrgyz legislation the national procedure of the state registration of a medical device or equipment should be conducted within not more than 50 calendar days and not more 30 calendar days for the simplified registration procedure from the date of payment confirmation of the official fees without consideration of the time for preparation of responses to requests (if any).

However, in accordance with the usual practice, depending on completion of the provided materials and scope of documentation, number of requests of the competent authority and other factors, the procedure of the state registration of a medical device in Kyrgyzstan lasts within about 3-4 months without consideration of the time for preparation of responses to requests (if any).

Validity term

The Certificate on the state registration of a medical device in the Kyrgyz Republic is valid on the permanent basis. Therefore, no renewal is required.

For more detailed information, including costs associated with registration of medical devices or equipment in Kyrgyzstan, list of documents required from your side for submission, sample of the Power of Attorney form for execution, etc., please contact our specialists directly.