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Russia Product Certification

Russia Product Certification


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GOST-R
Russian product certification introduction

GOST is a national technical standard specified by the Euro-Asian Council for Standardization, Metrology and Certification (EASC) and stands for GOsudarstvennyy STandart, which means federal standard in Russian.

GOST-R 로고



As the subject of the issuing certification body is different from the GOST certificate currently issued by country, each country's GOST certificate is a different certificate. Russia is called GOST-R, and Kazakhstan is called GOST-K.

Since the introduction of the EAC, an integrated certification system that took effect between customs alliance countries, the share of GOST-R certification in Russia has decreased significantly compared to the past. However, GOST-R certification is still required for import customs clearance for compulsory certification items that have not yet been negotiated between customs alliances.


✤ GOST R Certificate type

    GOST R CoC
    It is issued for objects that are obligated to obtain certification of conformity. GOST R CoC is a certificate that certifies that items and manufacturing process lines conform to Russian safety regulations for goods imported into Russia, and the issuance of GOST R CoC must be made by an accredited certification body.

    GOST-R 로고
    - GOST R Certificate -





    GOST R DoC
    GOST R DoC is issued for objects that are obligated to receive a declaration of conformity. The Declaration of Conformity (GOST R DoC) is a simplified type of certificate compared to the Mandatory Certificate of Conformity (GOST R CoC).

    GOST-R 로고
    - GOST R DoC certificate -





    GOST Voluntary
    GOST Voluntary is not a product that is obligated to obtain GOST certification, but it is a certificate that proves that the product is made in accordance with applicable regulations and guidelines. If a company receiving EAC certification additionally applies for GOST Voluntary, it is a company's publicity, securing trust, etc. Has the effect of.

    GOST-R 로고
    - GOST Voluntary Certificate -




✤ GOST R certificate validity period

    GOST R certification is valid for a minimum of 1 year and a maximum of 3 years.


✤ GOST R certification procedure

    1. Submit application form and product-related documents to the certification body
    2. Document review
    3. Check the type of certification applied
    4. Check whether sample test and factory audit is necessary
    5. Issuance of quotation and contract
    6. If a sample test is needed, the test proceeds after sending the sample and the test report is issued
    7. If factory audit is needed, proceed with audit
    8. Draft certificate issuance and customer verification
    9. Certificate issuance


✤ Documents to be submitted for GOST R certification

    - Application
    - HS Code
    - Product manual (Russian or exporting country language)
    - Existing test report
    - Existing certificate
    - Drawing (if applicable)
    - Technical documentation (if applicable)

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Why is it important?

  • After the introduction of the EAC, an integrated certification system that took effect between customs alliance countries, the share of GOST-R certification in Russia has decreased significantly compared to the past. However, compulsory certification items that have not yet been negotiated between the Customs Union countries still require GOST-R certification for import customs clearance.

  • Therefore, companies that wish to export goods to the Russian region must obtain a GOST R certification to demonstrate compliance with products that are subject to compulsory certification that have not been negotiated between the Customs Union countries. Only when the product, packaging, or attached document shows the GOST R conformity mark, can it be exported to the relevant country.

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IGC’s Competency

    The IGC certification body cooperates with the RUS-TEST PACIFIC certification body to provide the best competitive value to customers and stakeholders, and is reborn as a global certification body through continuous shared growth.

    IGC complies with:

    ❀ Comply with legal requirements

    ❀ Teamwork and solidarity among members

    ❀ Sincerity and fairness

    ❀ Social and environmental responsibility

    ❀ Continuous development and improvement activities through knowledge and learning as a certification and registration service provider

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Why IGC?

    IGC provides a competitive and satisfactory service to its customers through several strengths.

    ❖ Providing competitive services based on knowledge and technology secured through certification projects in various fields

    ❖ Competitive certification cost

    ❖ Minimum time required through rapid authentication service

    ❖ Provide One Stop Service for certification of various systems and products in fields other than Eurasia through subsidiaries

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Related Services from IGC

  • 01System certification

  • 02Product certification (European, Eurasia, U.S., China, Southeast Asia)

  • 03Product testing

  • 04Certification of auditor qualifications

  • 05Professional manpower training and education

Medical device registration in Russia
Introduction of product certification in Russia



Overview of Russian registration of medical devices

The medical device registration certificate, an official document issued by the Russian Federation Health Supervisory Authority, Roszdravnadzor, authorizes the relevant medical device to be suitable for production, import, sale and use in Russia because it has passed a preliminary assessment.

Not only medical devices produced in Russia, but all medical devices imported into Russia from abroad must be registered.

Classification of medical devices

    Names and classes for medical devices operating in Russia are listed in [Order N4H “About Conformation of Nomenclature Classification of Medical Devices”], and in vitro diagnostic equipment is not included. In vitro diagnostic equipment is subject to separate class regulations.

    ❖ Class 1 – Low risk

    ❖ Class 2a – Medium risk

    ❖ Class 2b – High risk

    ❖ Class 3 – Top risk

Medical device registration progress test type

    Testing according to medical device registration can only be conducted in laboratories registered in accordance with the 06.05.2011 N 352 Act, and for clinical trials, a list of institutions that can perform this function is posted on the Roszdravnadzor website.

    ❖ Toxicity test

    ❖ Functional test

    ❖ Electromagnetic inspection

    ❖ Clinical trial

Medical device registration validity period

    Permanent(valid until the product registered in the certificate is discontinued)


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Medical device registration process

      1. The agent of the enterprise must apply for a permit that Rosdravnadzor agrees to send the samples to Russia, which is valid for 6 months. In addition, the agent must provide a description of the applied product, a contract with the laboratory, and a contract with an attorney or manufacturer.

      2. The agent must go through the procedures to get the sample through customs. In addition to the samples, the representative must provide contracts, documents to be submitted to customs officials, and invoices.

      3. Toxicology tests, technical tests and electromagnetic wave tests of electrical products are conducted at accredited laboratory.

      4. (Simultaneous with step 3) The company must prepare all technical documents required for registration.

      5. The medical device is graded and, if there is no similar medical device registered in Russia, quality assessment, efficiency and safety tests are carried out as the first step. After that, clinical evaluations are conducted at two different medical institutions. A two-step quality assessment, efficiency and safety assessment are performed on medical devices.

      6. The entity submits the entire technical file to Rosdravnadzor. After completing the medical device registration, you must obtain the "GOST-R" certificate based on the registration certificate, the hygiene certificate according to the item, and the measuring instrument certificate according to the characteristics of the product.

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Medical device registration submission documents

      Manufacturer's power of attorney according to the registration and certification process (requires notarization)

      Certificates of company registration in the home country (eg, chamber of commerce, internal FDA registration, company registration certificate, business license) must be notarized and submitted

      ISO 9001 or ISO 13485 certificate issued by domestic or international organizations applicable to medical devices

      Certificate of conformity in accordance with the requirements of 93/42/EEC, declaration of conformity, free-selling certificate, FDA certification document, medical device certification document for domestic or other countries. (Must be notarized and submitted)

      Test report proving safety (IEC 60601-1, IEC 60601-1-2, ISO 10993, etc.)-Accurate test report can help to simplify work during technical inspection at the laboratory.

      Toxic safety/biocompatibility safety test report

      Providing samples for technical and toxicity testing

      Medical device new registration application or renewal registration application. The application must use the letterhead of the applicant (a legal entity authorized to conduct registration in Russia). The application must include a description of all components and parts included in the medical device or device. Applications must be submitted in Russian.

      Submit a power of attorney for appointment of a legal representative to perform the application. The manufacturing company must issue a power of attorney to a legal entity with registration authority (address to the head of the legal entity), and must be notarized in the country of origin of the manufacturer. It must also be translated into Russian and notarized by the Russian consulate in your country. The power of attorney must state that the manufacturer must entrust the applicant to sign a contract and receive a registration certificate to perform the registration of medical devices/equipment, consultation and professional work.

      The registration process does not require Good Manufacturing Practices (GMP) audits. However, legislation to introduce such audits will be implemented in the near future.

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Why is it important?

    All medical devices produced abroad and imported into Eurasia, as well as medical devices produced in Eurasia, must be registered with the Federal Health Supervisory Service. Medical devices can be imported and sold in Eurasia only after passing the pre-evaluation and registration.

    In order to register medical devices in Russia, even if tests were performed for approval by CE or FDA, a separate test, etc., conducted at an Eurasian authorized laboratory must be performed according to mandatory requirements. Russia does not accept internationally recognized certifications such as EU CE certification or US FDA approval, as Russia has not entered into a certification agreement with the EU or the US.


❉ ❉ ❉

IGC’s Competency

    The IGC certification body cooperates with the RUS-TEST PACIFIC certification body to provide the best competitive value to customers and stakeholders, and is reborn as a global certification body through continuous shared growth.
    IGC complies with:

    ⁙ Comply with legal requirements

    ⁙ Teamwork and solidarity among members

    ⁙ Sincerity and fairness

    ⁙ Social and environmental responsibility

    ⁙ Continuous development and improvement activities through knowledge and learning as a certification and registration service provider

Why IGC?

    IGC provides a competitive and satisfactory service to its customers through several strengths.

    ⁙ Providing competitive services based on knowledge and technology secured through certification projects in various fields

    ⁙ Competitive certification cost

    ⁙ Minimum time required through rapid authentication service

    ⁙ Provide One Stop Service for certification of various systems and products in fields other than Eurasia through subsidiaries


❉ ❉ ❉

Related Services from IGC

  • 01System certification

  • 02Product certification (European, Eurasia, U.S., China, Southeast Asia)

  • 03Product testing

  • 04Certification of auditor qualifications

  • 05Professional manpower training and education