State registration of medical devices

in Russia

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State registration of medical devices

Service available for:

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

State registration of medical devices in Roszdravnadzor is a mandatory procedure, without which it is impossible to enter the market for the devices, their 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

In the Russian Federation, the registration of medical devices is governed by Decree No. 1416 of the Government of the Russian Federation dated December 27, 2012. It defines the basic concepts and establishes the basic standards, rules, and terms of registration According to this Decree, the list of medical devices subject to mandatory state registration includes:

  • 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 (including those for contraception)

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

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

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 Russian Federation, the registration of medical devices includes the following stages:

  1. Collection of the dossier, 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 (for foreign products)

  4. Submission of the collected materials to the registration body

  5. Clinical trials

  6. Obtaining a registration certificate

State fee

State fee for the issuance of registration certificate of the medical devices

7,000 rubles

An expert examination of the quality, effectiveness, and safety of the medical device (depending on the potential risk class)

Class 1:

45,000 rubles

Class 2a:

65,000 rubles

Class 2b:

85,000 rubles

Class 3:

115,000 rubles

State fee for amending the registration certificate

1,500 rubles

Amending the documents containing in the registration dossier of the medical device

Class 1:

20,000 rubles

Class 2a:

30,000 rubles

Class 2b:

40,000 rubles

Class 3:

55,000 rubles

The final cost and terms will be calculated at your request

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Questions and Answers

1. Which body is involved in state registration of medical devices in the Russian Federation?

Federal Service for Surveillance in Healthcare 

1. Why do medical devices undergo testing?

To confirm that the device meets the declared technical characteristics, does not pose a danger to human health, and has clinical effectiveness