State registration of medical devices

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State registration of medical devices

Service available for:

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

State registration of medical devices in Uzbekistan is a mandatory procedure, without which it is impossible to enter the market for the devices, their free sale, purchase, and use

In the Republic of Uzbekistan, the registration of medical devices is governed by Decree No. 213, dated March 23, 2018, of the Cabinet of Ministers. It defines the basic concepts and establishes the basic standards, rules, and terms of registration

The main purpose of registration is to guarantee their safety for citizens’ health

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 following items are subject to registration and reregistration in the Republic of Uzbekistan: medicines, medical devices, and medical equipment manufactured in its territory and imported to its territory, including the following:
  • Equipment for treatment, prophylaxis, and rehabilitation

  • Apparatuses for the examination of health status

  • Accessories and consumables for specified equipment

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

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

  • The items imported for scientific research and those shown in exhibitions, fairs, and international forums 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

Adding changes to the registration dossier

Preparation and collection of the registration dossier

Development and 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 Uzbekistan, the registration of medical devices includes the following stages:

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

  2. Finalizing the dossier
    and preparation of documentation

  3. Conducting tests
    and examinations as well as obtaining permits for the import of test samples

  4. Submission of
    the collected materials to the registration body

  5. Laboratory testing

  6. Clinical trials

  7. Submission of the test report
    and its finalization as appropriate

  8. Obtaining a registration certificate

We will calculate the final cost and terms of registration at your request

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Questions and Answers

1. Which documents regulate the registration of medical devices in Uzbekistan?

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

3. What is included in the registration dossier?