If there are comments based on the results of the primary examination of documents, the authorized body notifies the applicant in writing of the need to eliminate them within a period not exceeding 45 calendar days from the date of notification. After the applicant eliminates the comments, the primary examination of the documents is repeated. The term for conducting a repeated primary examination should not exceed 10 calendar days. If the comments were not eliminated within the period specified in the notification, the result of the primary examination of the documents is recognized as negative.

The term for the primary examination of documents should not exceed 15 calendar days.

Registration of medical products in the Republic of Kyrgyzstan

Pursuant to Law No. 166 of August 2, 2017 "On Circulation of Medical Products", the registration of medical products is a procedure to confirm the compliance of a medical product with the requirements of quality, safety and efficiency for the purpose of circulation thereof. Assessment of the quality and safety of medical products is carried out by the Division for Quality Assessment of Drugs and Medical Product of the Department of Drugs and Medical Products under the Ministry of Health and Social Development of the Republic of Kyrgyzstan, which constitutes the authorized body.

National registration in the Republic of Kyrgyzstan, as well as in the Republic of Kazakhstan, requires the appointment of an authorized representative of the non-resident manufacturer in the territory of the Republic of Kyrgyzstan.

At the moment, it is possible to obtain registration of a medical product for the purpose of its circulation in the territory of the Republic of Kyrgyzstan under the following provisions:

1. Preparation of the Application and compilation of the Registration Dossier. Submission of a set of documents to the authorized body, including:

· Application and Registration Dossier;
· Samples of medical products within the quantity necessary for research (testing);
· Specific reagents within the quantity necessary for research (testing).

2. Assessment of the completeness and comprehensiveness of the documents included in the scope of the Registration Dossier, as well as determination of compliance of the class of potential risk of use of the medical product with the class specified by the manufacturer in the documents of the Registration Dossier.

Conducted by the authorized body within 10 working days from the date of application submission.
In case there are comments based on the results of the initial examination of documents, the authorized body shall notify the applicant in writing of the need to eliminate them within a period not exceeding 30 working days from the date of notification.

3. In case of a positive conclusion of the authorized body on the results of evaluation on completeness and comprehensiveness of the documents included in the scope of the Registration Dossier, the applicant shall make payment not later than 21 working days from the date of submission of the invoice for payment.

4. Examination of the safety, efficiency and quality of a medical product, which includes:

• Analytical expertise (if necessary);
• Specialized expertise.

Analytical examination of a Medical Product (excluding in vitro diagnostic products) includes:

1) technical testing (research) of medical products and research (testing) to assess the biological effect of medical products;

2) verification of reproducibility of methods of analysis of registration samples.

Analytical examination of medical products shall be carried out by organizations accredited in accordance with the established procedure. The results of analytical expertise shall be sent to the authorized body for specialized expertise within a period not exceeding 30 working days.

Specialized expertise of Medical Equipment is conducted by the authorized body to obtain a scientific assessment of the safety and efficiency of medical products and shall include:

1) Analysis of documents and materials governing the safety, efficiency and quality of the medical product, including consumables and component parts for the medical product;

2) Analysis of the proper determination of the nomenclature of a medical product as per the applicable nomenclature of medical products;

3) Analysis of technical testing protocols, reports on the evaluation of the biological effect of the medical product, and evaluation of clinical data contained in the clinical evidence report on the efficiency and safety of the medical product;

4) Initiation, if necessary, of manufacturing inspections;

5) Evaluation of the user manual (instructions for medical use) and operational documentation;

6) Evaluation of medical product labeling;

7) Preparation of an expert opinion on the assessment of safety, efficiency and quality of a medical product.

The manufacturing inspection shall be carried out by the authorized body in the following cases:

• Production of a medical product previously registered within the Republic of Kyrgyzstan has not been subjected to production inspection;
• Production of the medical product is carried out at the applicant's first declared manufacturing site;
• When applying for registration of the first reproduced medical product;
• In cases where it is impossible to conduct an analytical examination due to the high cost of samples of medical products, the inability to comply with the conditions of transportation of these samples and/or their storage, the lack of dedicated equipment and consumables. Technical testing (research) in this case shall be conducted in the presence of representatives of the authorized body in the quality control laboratory of the manufacturer of the medical product or in the contract laboratory used by the manufacturer;
• Inability to assess the reliability of data on safety, efficiency and quality of the medical product based on the documents presented in the Registration Dossier.

The time period for organizing and conducting the inspection is not included in the total time period for the examination and shall not exceed 90 calendar days in the aggregate.

5. Adoption of a decision on state registration of a medical product based on the results of conducted expert examinations within a period not exceeding 3 working days, execution of a registration certificate within 10 working days from the date of issuance of an order on state registration of a medical product.

Our task

Entrusting the task of registering your medical device to us, you can be sure that we will ensure successful registration throughout the EAEU: in the Republic of Kazakhstan, in the Russian Federation, in the Republic of Belarus, in the Kyrgyz Republic and in the Republic of Armenia

We provide professional assistance in the development, correction and preparation of all necessary documents of the registration dossier, the main of which are:

- application for state registration of a medical device;
- information about regulatory documentation for a medical device;
- manufacturer's (manufacturer's) technical documentation for the medical device (extract from the technical file/technical specifications, risk management file, manufacturer's reports, qualification test reports);
- operational documentation of the manufacturer (manufacturer) for the medical device;
- documents confirming the results of technical tests of a medical device;
- documents confirming the results of toxicological studies of the medical device;
- documents confirming the results of tests of a medical device in order to approve the type of measuring instruments;
- documents confirming the clinical efficacy and safety of medical devices

The group of companies "Electrontest" includes its own testing base, namely: technical testing laboratory of IL TSB LLC "Electrontest"; toxicological testing laboratory "ElectrontestBio", the main activity of which is testing of medical devices and medicines for biological safety, as well as a clinical diagnostic laboratory accredited for conducting technical, clinical tests of MI in vitro. The powers of all laboratories are confirmed by relevant documents. We guarantee that all tests, if necessary, will be carried out at the highest level, and the test results will be obtained in accordance with all necessary requirements and within a clearly defined time frame.

In its work, the company Electrontest LLP relies on many years of experience of its employees in the registration of medical products and in-depth familiarity with regulatory documents. We ensure a comprehensive approach to the registration procedure. If necessary, we, together with the testing centers of the Electrontest Group, ensure the full range of medical product testing: technical, toxicological, clinical and clinical-laboratory testing of In Vitro products.

Phases of Registration in the Republic of Kyrgyzstan

You can save precious time and money by working with us, as we will undertake the preparation of all necessary documentation in accordance with the requirements of regulatory documents and regulatory bodies, as well as support the registration process after the submission of documents to the authorized body.

Astana, st. Anet baba, 9/3

+7 (776) 326 2500
+7 (702) 999 1964
+7 (701) 419 2225

Our work is based on a deep knowledge of regulatory documents, an understanding of the physics of processes in medical devices, the high qualification of our experts and, most importantly, on our own test base.

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_{For request:}
electrontest.kz@gmail.com