State registration of medical devices

in Kyrgyzstan

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State registration of medical devices

Service available for:

  • Russia
  • EEU
  • Kazakhstan
  • Belarus
  • Kyrgyzstan
  • Uzbekistan

State registration of medical devices (MD) in the Department of Medicine Provision and Medical Equipment under the Ministry of Health of the Kyrgyz Republic (DMPaME MH KR) is a procedure of effectiveness and safety determination of medical devices based on appropriate testing and assessment for admission to manufacturing, importation, exportation, sale, and medical use of the medical devices

During the procedure, the quality of the products and their compliance with current norms and standards are inspected. Only truly high-quality and efficient medical products successfully pass all checks and are included in the register


Items for registration

The list of medical products subject to mandatory state registration includes the following products:

  • Created for the first time in the Kyrgyz Republic and proposed for medical use in the Kyrgyz Republic

  • Manufactured in other countries and first proposed for medical use in the Kyrgyz Republic

  • Analogous to the registered ones but manufactured by another manufacturer

Used and refurbished devices intended for sale outside the Kyrgyz Republic, those imported by an individual for personal use, spare parts intended for repair, and exhibition samples are not subject to registration

What problems may arise if you decide to do the registration yourself?

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

The benefits of registration with the MedExpert company:

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process

List of services

Consulting

Preparation and collection of the registration dossier

Organization of the assessment in the production environment

Interaction with registration bodies

Registration stages

According to the current rules in the Kyrgyz Republic, the registration of medical devices includes the following stages:

  1. Collection of the dossier
    and submission of the application to the authorized bodies

  2. Primary expert
    examination of the documents

  3. Inspection of the manufacturing
    of medical devices

  4. Analytical expert examination,
    including technical testing, biological effect assessment, and verification of reproducibility of analytical procedures

  5. Specialized expert examination
    to obtain a scientific assessment of the safety and effectiveness of medical devices and the benefit–risk ratio of medical devices

  6. Conclusion on the assessment
    of the safety, effectiveness, and quality of the medical device submitted for registration

  7. Obtaining a registration certificate

The final cost and terms will be calculated at your request

By pressing the “Send” button, you confirm that you give the company your consent for processing your personal data

Questions and Answers

1. Which body is involved in the state registration of medical devices in the Kyrgyz Republic?

The Department of Drug Provision and Medical Equipment under the Ministry of Health of the Kyrgyz Republic

2. Which documents are required for registration?

1. Application for the registration of the medical device
2. A power of attorney or a certified copy of the contract if the applicant is not a manufacturer of the medical device
3. Documents confirming compliance of medical devices with the requirements of regulatory legal acts (certificates, test records, registration certificates, etc.)
4. Standardization document* for a medical device or a substitute document (technological regulations for production, specification, etc.)
5. User manual* for a medical device and/or instruction for medical use
6. Clinical trial conclusion or medical expert examination report

Note:
1. *These documents may be submitted in an electronic form (i.e., in pdf format) and in paper.
2. All documents are submitted in two copies.
3. All documents for registration of the medical device must be presented in the state and/or official language or have a certified translation into the official language.
4. Copies of documents must be clear and legible, including their stamps and signatures.
5. For local manufacturers, draft documents are submitted under items 4–5.
6. Documents after the expert examination are not returned, except for signed documents under paragraphs 5–6 for local manufacturers.
7. When registering/reregistering additional unit sizes of medical devices, the applicant submits a separate application and registration dossier.


3. In which cases is it necessary to amend the issued certificate?

If the manufacturer has reorganized, its name, address, or title has changed, as well as if the name of the medical device itself or the composition of accessories, components, and consumables have changed, provided there is no effect on the functional characteristics