State registration of medical devices

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State registration of medical devices

Service available for:

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

Registration of medical devices intended for circulation in the territory of the Eurasian Economic Union (hereinafter referred to as the Union) is a mandatory procedure, without which it is impossible to enter the market for their products, free sale, purchase, and use

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

Items for registration

Within the territory of the Customs Union, the registration of medical devices is regulated and conducted in the manner prescribed by the Rules for registration and expert examination of the safety, quality, and effectiveness of medical devices approved by the decision of the EEC COUNCIL No. 46 dated 02/12/16. It determines the basic concepts, and the basic standards, rules, and terms of registration are set According to this Decree, the list of medical devices subject to mandatory state registration includes the following:
  • Equipment for treatment, prophylaxis, and rehabilitation

  • Accessories and consumables for specified equipment

  • Instruments for monitoring and self-monitoring of patient’s health

  • Apparatuses for the examination of health status

  • Devices and tools for restoring or changing physiological functions and human anatomy

Only those devices that are manufactured under individual orders and do not go on free sale 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 registration process

List of services

Consulting

Adding changes to the registration certificate

Preparation and collection of the registration dossier

Adding changes to the registration dossier

Analysis of technical documentation

Interaction with registration bodies

Support in testing

Interaction with registration bodies

Registration stages

According to the current rules within the territory of the Customs Union, the registration of medical devices includes the following stages:


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

  2. Finalization of the dossier
    and preparation of documentation

  3. Testing and examinations
    as well as execution of import permission for test samples

  4. Submission of the collected materials
    to the registration body

  5. Expert examination
    of the medical device

  6. Inspection of manufacture
    of the medical device

  7. Harmonization of the expert opinion
    by the Member States concerned

  8. Registration of the medical device

We will calculate the final cost and terms of registration 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. Until what period is it necessary to reregister all medical devices following the requirements of the EEU?

2. Who can be an applicant when registering under the requirements of the Customs Union?

3. What is included in the registration dossier?