State registration of medical devices

in Belarus

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State registration of medical devices

Service available for:

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

State registration of medical devices and medical equipment is a system of access to the manufacturing, sale, and medical use of medical devices and medical equipment manufactured in the Republic of Belarus or received from abroad, which are recognized as meeting the safety, efficiency, and quality requirements established in the Republic of Belarus

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

The list of medical devices and medical equipment subject to mandatory state registration includes the following devices:

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

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

  • Previously registered and proposed for use for a new medical indication

  • Equivalent to the registered ones but manufactured by another manufacturer

Used and refurbished devices intended for sale outside the Republic of Belarus, those imported by an individual for personal use, and spare parts intended for repair 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

Introducing changes to the registration certificate

Preparation and collection of the registration dossier

Introducing changes to the registration dossier

Analysis of technical documentation

Collaboration with testing centers

Support in testing

Interaction with registration bodies

Registration stages

According to the current rules in the Republic of Belarus, 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 manufacture of medical devices
    and medical equipment

  4. Sanitary and hygienic tests of medical devices
    and medical equipment of domestic and foreign origin

  5. Technical testing of medical devices
    and medical equipment of inner origin

  6. Specialized expert
    examination of documents required for state registration (reregistration) of medical devices and medical equipment

  7. Clinical trials/Clinical assessment
    based on clinical data and evidence of equivalence of medical equipment previously registered in the Republic of Belarus

  8. 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 documents regulate the registration of medical devices in Belarus?

1. Belarus-List of documents-medical device
2. The Law of the Republic of Belarus on June 18, 1993 No. 2435-XII “On Health Care”
3. Resolution of the Council of Ministers of the Republic of Belarus on September 2, 2008 No. 1269

2. Which body is involved in state registration of medical devices in the Republic of Belarus?

Ministry of Health of the RB
A set of preliminary technical works is conducted by the Republican Unitary Enterprise “Center for Examinations and Tests in Health Service.”

3. In which cases is it possible to include several modifications of a medical device and medical equipment in a single registration certificate?

It is possible under the following conditions:
- modifications of a medical device are performed by a single manufacturer of a medical device according to a single technical documentation
- modifications of a medical device related to the same class of potential risk of use
- the presence and/or quantitative content of the same clinically/diagnostically significant analyte(s) in a biological sample (for reagent components)
- modifications of a medical device have various assemblies that do not affect the principle of performance and functional use
- modifications of a medical device have various technical parameters that do not affect the principle of performance and functional use (by applicability)
- modifications of a medical device form a series of sizes, shapes, and color coding or are a performance group of a medical device