TRCU EAC certification type

TRCU certificates are classified into two categories: Certification of Conformity (CoC) and Declaration of Conformity (DoC) according to the details.

⁘TRCU CoC
This includes pressure vessels, hand tools, cranes, elevators, some machinery, test equipment, electrical and electronic products, etc., and a sample test or factory inspection is required.

⁘TRCU DoC
This is a general product with relatively low risk, and some products can be issued certificate by only document review. In the case of CoC, product tests are conducted through designated testing laboratories in principle, but a number of certification agencies are issuing certificates after acknowledging CB safety reports without additional tests.



EAC CoC
EAC DoC

TRCU EAC certification validity period

⁘ One-Shipment (Single Delivery Certification): This is mainly in cases where products are exported on a one-off basis, such as plants, and in cases where resale to third parties or other general consumers is not possible, and is valid until the contract fulfillment period indicated in the contract with the importer.

⁘ Serial Production Certification: This is advantageous in cases where continued export is expected, and one certification can result in a certificate valid for up to 5 years.

TRCU EAC certification process

1. Submit application form and product-related documents to the certification body

2. Document review

3. Check the type of certificate applied

4. Check the Sample test and factory inspection

5. Issuance of quotation and contract

6. If sample test is needed, test and test report is issued after sending sample

7. If factory inspection is necessary, proceed with the inspection

8. Draft certificate issuance and customer verification

9. Certificate issuance

TRCU EAC submission documents

The documents to be submitted by the manufacturer are as follows: (Not limited to this, but can be added as needed.)

⁘ application

⁘ HS Code

⁘ Product manual (Russian or exporting country language)

⁘ Existing test report

⁘ Existing Certificate

⁘ Drawing (if applicable)

⁘ Technical document (if applicable)

Eurasian certification applicant (Eurasia Representative)

TRCU certification and GOST R certification are registered on the Rosakkreditasiya website.
Go to Rosakkreditasiya website (https://www.fsa.gov.ru/) ☜ Click!

-When applying for TRCU certification, GOST R certification, etc., only companies located in Russia or other customs union countries can become the applicant. The company must be a legal entity or a private business, and the general public can’t be an applicant for certification.

-IGC provides the Eurasia Representative service for customers who don’t have a business operator who can act as an applicant in the Eurasia region.

Why is it important?

Companies wishing to export products to the Eurasian region must obtain certification proving conformity to the applicable technical regulations and mark the conformity mark on the product, packaging or attached documents to be exported to that country.

IGC’s Competency

IGC 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:

⁘ Compliance with legal requirements

⁘ Teamwork and solidarity among members

⁘ Sincerity and fairness

⁘ Social and environmental accountability

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

Classification of medical devices

Nomenclature and classification of 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

Test type of Medical device registration progress

Testing according to medical device registration can only be conducted in laboratories registered under the 2011 N 352 Act of 06 May 2011, 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.)

Medical device registration process

1. The representative of the company must apply for permission to consent to sending samples to Russia by Rosdravnadzor, which is valid for 6 months. In addition, the representative must provide a description of the applied product, a contract with the laboratory, and a contract with an attorney or manufacturer.

2. The representative must check in to get the sample through customs. In addition, the representative must also provide samples, contracts, documents to be submitted to customs officials, and invoices.

3. Toxicity tests, technical tests, and electromagnetic tests are conducted in the case of electrical products at accredited laboratory.

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

5. If the class of medical devices is determined, and there is no similar medical device registered in Russia, quality evaluation, efficiency and safety tests are conducted as the first step, and then clinical evaluation is carried out at two different medical institutions. Quality assessment, efficiency and safety assessments are carried out.

6. The company submits the entire technical file to Rospotrebnadzor. After completing the registration of medical devices, GOST-R certificate, hygiene certificate for each item, and measuring instrument certificate according to the characteristics of the product must be secured based on the registration certificate.

Medical device registration submission documents

∷ Manufacturer's power of attorney following the registration and certification process (requires notarization)

∷ Proof of company registration in the home country (for example, chamber of commerce, internal FDA registration or company registration certificate, business license) must be notarized and submitted.

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

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

∷ Test reports proving safety (IEC 60601-1, IEC 60601-1-2, ISO 10993, etc.)-Accurate reports can help to simplify work during technical inspections in laboratory.

∷ Toxic Safety / Biocompatibility Safety Test Report

∷ Providing samples for technical and toxicity tests

∷ Medical device new registration application or renewal registration application. The application must use the letterhead of the applicant (a legal entity authorized to carry out 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 the 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 stipulate that the manufacturer must entrust the applicant to sign a contract to perform registration of medical devices/equipment, perform consultation and professional work, and obtain a registration certificate.

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

∎. In general, the fee of registration depends on the scope of testing required.

Medical device registration confirmation

You can check the registration status of medical devices on the website of Rospotrebnadzor in the Russian version.

☞ Go to Rospotrebnadzor website ☜
Website address ==> http://roszdravnadzor.ru/registration/mi/login

For medical devices of Class 1 and 2a, if the products are similar (same grade, applied in the same way, same efficiency), both products are registered on the basis of equivalent or technical testing, safety.

All other products including Class 2b, 3, 1 and 2a (if no similar product has already been registered) are registered on the basis of technical tests, safety assessments, clinical and medical tests to confirm effectiveness and safety.

1. Eurasian Product Certification (EAC) (EAC)

TRCU abbreviated for Technical Regulation of Customs Union and stands for the technical regulations of the Customs Union centered on Russia.

TRCU is an integrated certification system that began with the Eurasian Customs Union “EACU, Eurasian Customs Union” formed by Russia, Kazakhstan and Belarus in 2010, and entered into force in the Eurasian Economic Union “EEU, Eurasian Economic Union” in 2015.

Currently, the Eurasian Customs Union/Economic Union consists of five countries: Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia, and TRCU certification follows the stipulated certification procedure according to the decision of the Eurasian Economic Commission.

The EAC mark is affixed on the certificate, which means Eurasian Conformity.

1) TRCU EAC applied items (food)

TRCU EAC applied items (food)




∷ TR СU 015/2011 On safety of grain

∷ TR CU 021/2011 On safety of food product

∷ TR СU 022/2011 On food products in terms of its marking

∷ TR CU 023/2011 On juice production of vegetables and fruits

∷ TR CU 024/2011 On oil and fat products

∷ TR CU 027/2012 On safety of certain types of specialized food products, including foods for dietary treatment and dietary preventive nutrition

∷ TR CU 029/2012 Requirements for the safety of food additives, flavorings and technological aids


∷ TR CU 033/2013 On safety of milk and dairy products

∷ TR CU 034/2013 On safety of meat and meat products

∷ TR CU 040/2016 On safety of fish and fish products

∷ TR CU 044/2017 On the safety of packaged drinking water, including natural mineral water

∷ TR CU 047/2018 On safety of alcohol products

2) EAC certificate type

This is a general product with relatively low risk, and some products can be issued certificate by only document review. Food is subject to the EAC DoC.

3) EAC certification information

Documents to be submitted: application form, product manual, HS Code, drawing, technical document, test report, certificate (Documents to be submitted must be written in Russian) ∷ Sample test: Depending on the product, it is decided whether to submit and test the sample. ∷ Factory inspection: None ∷ Duration: 2 weeks (Excluding sample delivery and sample testing period) ∷ Certificate validity period: up to 5 years (Serial Production Certification)

2.Eurasian Product Certification (GOST)

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

Currently, GOST certificates issued by country and the subject of issuing certification bodies are different, so each country's GOST certificate is a different certificate, and it is classified as GOST-R in Russia and GOST-K in Kazakhstan.

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

1) GOST applied items (food)

After the introduction of the integrated certification system that took effect between the countries of the Eurasian Customs Union such as meat, fish, shellfish, vegetables/fruits, grains, citrons, alcohol/drinks, etc., the share of GOST certifications in Russia has decreased significantly compared to the past.

However, compulsory certification items that have not yet been negotiated between allies must be certified by GOST.

In addition, EAC-certified companies may additionally apply for a voluntary GOST certificate for customer promotion and trust.

2) GOST certificate type

✤ GOST DoC (Declaration of Conformity)

✤ GOST Voluntary

GOST Voluntary is a certificate that proves that the product has been made in accordance with applicable regulations and guidelines, although it is not mandatory to obtain GOST certification.

The additional acquisition of the GOST Voluntary Certificate will have the expected effect of more clearly demonstrating your management capabilities, thus securing the effect of increasing exports.

3) GOST certification information

✤ Documents to be submitted: application form, product manual, HS Code, drawing, technical document, Existing test report, Existing certificate (Documents to be submitted must be written in Russian)

✤ Sample test: Depending on the product, it is decided whether to submit and test the sample.

✤ Factory inspection: None

✤ Duration: 2 weeks (Excluding sample delivery and sample testing period)

✤ Certificate validity period: up to 3 years (Serial Production Certification)

4) Certification process

TRCU EAC, GOST and State Registration Certificate certification process

1. Submit application form and product-related documents to the certification body

2. Document review

3. Check the type of certificate applied

4. Check the Sample test and factory inspection

5. Issuance of quotation and contract

6. If sample test is needed, test and test report is issued after sending sample

7. If factory inspection is necessary, proceed with the inspection

8. Draft certificate issuance and customer verification

9. Certificate issuance

3. State Registration Certificate

The hygiene registration certificate issued by each country has been integrated into one certificate according to the Decision of CU commission No.299 adopted in 2010 by the Customs Union.

One certificate can be used in all 5 countries of the Eurasian Customs Union (Russia, Kazakhstan, Belarus, Kyrgyzstan, Armenia).

1) Food products to which national hygiene registration is applied

✦ Mineral water, bottled water, soft drinks, alcohol-including low alcohol and tonic drinks

✦ aby food, food for pregnant and breastfeeding women, dietary products, food for athletes, biologically active food additives, organic products, specialty foods including supplements

✦ Food additives (plant extracts, aromas, etc.)

✦ Food produced using genetically modified (transgenic) organisms

✦ Materials, devices, equipment and other technical products for use in drinking water supply

✦ Food contact products (excluding cutlery, tableware, and manufacturing equipment)

2) National hygiene registration certification information

✦ Sample test: Depending on the product, sample submission and testing are decided.

✦ Factory inspection: Depending on the product, factory inspection may be required, and inspection M/D and fee are determined through quotation.

✦ Duration: 4~6 weeks (excluding sample sending and sample testing period)

✦ Validity period of certificate: 5 years

✦ Certification fee: It is different for each product, so consultation is required for accurate quotation.

4. IGC인증원의 역량

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 fee

⁙ Minimum time required through rapid certification service

⁙ Provides One Stop Service for various system and product certifications

The need to comply with the Drug Distribution Act (#61-FZ)

According to the current law, violations of the law on the distribution of drugs are subject to penalties under the laws of the Russian Federation.

The relevant laws are:

1. Resolution of the Government of the Russian Federation Article 5.1.4
Health monitoring service (No323, 2004/06/30).
State oversight includes the organization and conduct of inspections for compliance with the circulation of pharmaceuticals with requirements for the distribution, transportation, dispensing, sale of pharmaceuticals, and use of pharmaceuticals.

2. Federal Law Regulations (#294-F3, 2008/12/26)
It is about the protection of the rights of corporations and private companies in the implementation of state control (supervision) and local governments. Monitoring the integrity and quality of state supervision includes conducting inspections, identifying and eliminating violations of the applicant's rights, violating essential requirements, applying measures to contain the violation, and eliminating the consequences of such violations, reviewing, making decisions and preparing responses to the applicant's appeal.

Therefore, if your company wants to distribute medicines in Russia, you must comply with the Drug Distribution Act and other relevant laws.

Product license registration

In order to register an import license, product registration must be preceded to the Russian Federation Health Supervisory Service (ROSZDRAVNADZOR). Product registration requires registration review and clinical trials conducted by the Federal Health Supervisory Service. The registration review is determined within the 210-day period excluding the clinical trial period, and document review, production process review, and sampling type test are required.

In the case of clinical trials, the requirements for preclinical and clinical trials established by federal law of drug distribution and other regulatory laws of Russia must be complied. In accordance with Article 4, Paragraph 40 of the Drug Distribution Act (#61-FZ/2010.04.12), preclinical testing is defined as biological, microbiological, immunological, toxicological, physical testing, and stability testing of pharmaceuticals by other scientific evaluation methods. For clinical trials, this includes research into the diagnosis, treatment, prevention and pharmacological properties of a drug.

This includes interactions with other pharmaceuticals and foods, not limited to processes such as absorption, allocation and transformation by scientific methods.

Application for import permit

After the drug is registered with the Federal Health Supervisory Service, you can apply for an import license, and all drug certifications that are initially registered are valid for five years. After that, upon renewal, the certificate of the approved drug is indefinitely valid.

In addition to issuing a drug registration certificate, it is also necessary to obtain a Certificate of Conformity or a Declaration of Conformity according to Russian certification GOST R.

Products subject to certification

According to the legislation of the Russian Federation government (#982, 2009.12.01), the items that require certification are immunoglobulins, gamma globulin, serum, toxins, medical and veterinary vaccines. Items subject to the declaration of conformity include drugs, pharmaceutical chemicals, coenzymes, enzymes, amino acids, vitamins, organic products, and veterinary serum.

Benefits of pharmaceutical certification: prospects of expanding Eurasian pharmaceutical certification

Eurasian countries that require drug certification are expected to increase further. Currently, the member countries of the Eurasian Economic Union are in the process of forming a pharmaceutical market community as in the case of medical devices.

✦ On December 23, 2014, Russia, Belarus and Kazakhstan signed an agreement on common rules and principles for drug distribution within the EEC.

✦ and applied about 26 regulations including No. 78 Drug Registration Inspection Regulation (November 3, 2016) (Applicable date: 2017.05~)

Therefore, the effectiveness and application of drug certification will be expanded.

EAEU drug distribution regulation

On May 5, 2017, the Eurasian Economic Commission announced that the 26-document EAEU drug distribution regulation came into effect on May 6, 2017. Transnational regulations apply to drug development, preclinical and clinical research, quality control, registration, production and distribution, while national regulations include preclinical and clinical trials, pricing, retail, public procurement, cost reimbursement, and advertising.

There is a grace period until December 31, 2020, so if you need a registration certificate, you can choose between EAEU and national regulatory systems to apply. If applying for registration before December 31, 2018, EAEU manufacturers were required to submit according to the country-specific regulatory system instead of the EAEU GMP certificate. All drugs registered in accordance with the regulations prior to December 31, 2020 must be re-registered in accordance with the regulations of each market by December 31, 2025.

IGC’s Competency

✥ IGC is providing certification services for medicines in cooperation with RUS-TEST PACIFIC, an Eurasian regional certification service provider.

✥ IGC auditors are contributing to the continuous development of customers by accurately evaluating the suitability through the technology and expertise accumulated over the years.

✥ IGC is a reliable global leader in Eurasian certification, providing certification for medical devices, cosmetics, food and EAC certification as well as pharmaceuticals.

✥ IGC has up-to-date knowledge of a wide range of specific scope and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.