Declaration and certification of products

in Russia

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Declaration and certification of products

Service available for:

  • Russia

Declaration and certification of products are the forms of mandatory confirmation of products compliance with established safety standards and requirements

The list of products subject to mandatory certification and declaration is specified in the Decree of the Government of the Russian Federation 982 from 01.12.2009


Items to declare

The legislation establishes mandatory declaration in the GOST R system for such groups of medical goods as follows:

  • Medical devices

  • Therapeutic and diagnostic instruments

  • Measuring instruments

  • Surgical materials

  • Implants for surgery and dentistry

  • Dental materials

  • Medical tools

  • Prosthetic and orthopedic products

  • Medical devices from polymer materials

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

Laboratory testing

Issuance of products’ testing report

Issuance of Declaration of Compliance

Declaration stages:

According to the rules applicable in the Russian Federation, the declaration of medical devices includes the following steps:

  1. Determination of
    declaration scheme

  2. Formation of
    evidentiary materials

  3. Issuance of
    Declaration of compliance

  4. Registration of
    declaration of compliance

  5. Marking
    an appropriate mark

  6. Provision of
    compliance

The final cost and terms will be calculated at your request

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Questions and Answers

1. Which documents are needed for registration?

For Russian goods: 

- Application
- Certificate of assignment of the taxpayer ID number
- PSRN certificate
- Statistic codes
- Normative and technical documentation - GOST (CU) or TU
- Description of a product: area of usage, main material, product number, trademark, etc.


For imported goods: 

- Application
- Certificate of assignment of the taxpayer ID number
- PSRN certificate
- Statistic codes
- Copy of the contract between the applicant and manufacturer
- Information about manufacturer and address
- Invoice or specification to the contract
- Description of a product: area of usage, main material, product number, trademark, etc.