EAC Certificate, EAC Declaration, Fire Certificate, State Registration Certificate, Vehicle Type Approval Certificate (OTTC), Medical Registration Certificate, Exemption Letter, Gost-R Certificate, Kazakhstan Gost-K Certificate, Explosion Proof Equipment Compliance Certificate, Russia Sea and River Ship Registration Certification  …

Services are provided related to all required certification processes in EAC member countries, especially in the Russian Federation,

EAC Certificate and EAC Declaration

The EAC Product certification system is a document issued in line with the standards set by the states to the common customs union procedure organized by the Russian Federation regulatory board. The main task of the certification system is to control the quality and safety aspects of products entering the country borders of the Russian Federation, Belarus, Kazakhstan, Armenia and Kyrgyzstan before they are released for free circulation. Compliance of products with the requirements of current standards and the requirement for approval are protected by the legislature.

After the establishment of the Customs Union system, it was determined which industrial branches will be included in this scope, and all technical regulations within this framework were established. According to these technical regulations, a representation system with authority over the certificate should be established in the territory of these member states.  The representation system referred to as Zayivitel in the regulation is mandatory. A certificate is issued on behalf of the buyer or representative system in the relevant member country.  The name of the manufacturer is only mention on the producer part.  The EAC Certificate is usually given for 5 years and 4 years for some different situations. And since it is a printed document, it cannot be added or removed later.

After the relevant product is certified, it is marked with EAC Marking. This sign is located on the manufacturer’s label along with the consumer information form. EAC Certificate or Declaration (varies according to the product groups) pricing is made in accordance with the following information;

Product name – Brand and Model Information – HS Code – Information about from which material it is made of and where to use it – Technical Specifications

  • If there is no catalog, product photos are mandatory.
  • ISO Documents of the company, if any
  • Is there a representative? INN and OGRN information if available
  • Fire Certificate

The certificate, also known as the Fire Safety Certificate, is a mandatory document that must be given to equipment and product groups in accordance with the legal regulations of the Customs Union countries and in line with the relevant standards.

2 groups of products must obtain this certificate.

  • Fire Safety Equipment and materials produced for this purpose
  • Equipment and materials used in construction interior decoration ,

The Fire Certificate is a special regulation that needs to be defined in the light of procedures such as product design, production and working principle. In case of fire protection and prevention for every applicable requirement, it has to fulfill the processes established for the safety of people and protection of property without exception. The Fire Certificate is given for 1 to 5 years, depending on the product. However, the duration of the Fire Certificate does not exceed 5 years, as is not the case with any certificate.

With the change in the relevant regulation in January 2020, the fire certificate, which was not within the scope of EAC, is now included in the scope. While acting in line with their national standards for each member country according to the old technical regulation, an expansion has been made to cover all member countries with the new regulation.

  • Russian Metrology Certificate

Type Approval Certificate (Metrological Certificate) is a mandatory document that verifies that the measuring device conforms to the determined norms and conditions. In accordance with Federal Law No. 102-FZ of 13 July 2015 “On Ensuring Equality of Measurements”, the regulation of this document is issued by the Federal Agency for Technical Regulation and Metrology – Rosstandard.

Some of the Products within the Scope of Measuring Instrument Type Approval Certificate:  :

  • Weighing instruments and other measuring instruments for the domestic market
  • Industrial Measuring Instruments
  • Tools for geodetic hydrological activities
  • Devices for environmental activities
  • Security Tools
  • National defense tools for state events
  • Measuring instruments used in sports in the Olympics, etc.

The validity period of the Measuring Instrument Type Approval Certificate is 5 years.

  • SGR Certificate – State Registration Certificate

SGR Certificate is issued by Rospotrebnadzor. Generally, SGR Certificate is used throughout the product manufacturing period and / or representation. So there is no time limit. Of course, otherwise, it can be done. With a change in the relevant regulation, even if your products are covered by SGR indefinitely, they may have been removed from the scope or different requirements may be needed. For this reason, even if you do not make a difference in your products before your exports, it is useful to contact us about the situation.

The list of products that require a State Registration Certificate in accordance with the Customs Union Commission Decision No. 2999 dated 28 May 2010; Products requiring state registration certificate are specified in the customs border and the list of combined goods subject to sanitary and epidemiological monitoring within the borders of the Customs Union.

Products within the scope of the State Registration Certificate

  • Mineral water, bottled drinking water, soft drinks, alcoholic beverages (including low alcohol and tonic drinks)
  • Specialty products: baby food, food for pregnant and breastfeeding women, dietary products, food for athletes, dietary supplements, organic products, nutritional supplements
  • Nutritional supplements complex (herbal extracts, flavors, etc.)
  • Food products obtained using genetically modified (transgenic) organisms
  • Cosmetics, oral hygiene products
  • Household chemicals
  • Disinfectant, resources for rat disposal
  • Potentially dangerous chemical and biological substances
  • Materials, equipment, tools and other technical products for water purification intended for domestic water supply
  • Products used in contact with food products (excluding cutlery, plates, process equipment)
  • Personal care products for children and adults, children’s clothing and products used for nutrition
  • Vehicle Type Approval Certificate (OTTC)

Vehicle Type Approval Certificate is a mandatory document that ensures the production, import and registration of new vehicles in the Customs Union. Vehicle Type Approval Certificate is a document confirming the safety of new vehicles within the framework of the technical regulations of the Russian Federation and Customs Union. Vehicle Type Approval Certificate is given for a maximum of 3 years in mass production. For vehicles that produce as a batch, this document is indefinite, but the validity period may change with the entry into force of new legal regulations and standards.

Vehicle Type approval is done as E marking in line with the 2007/46 standard. The OTTC process does not include this certification. Even if the homologation processes of your vehicles are made according to the relevant directives, it is mandatory to obtain an OTTC Certificate by making a relevant application before being sent to the Customs Union member countries.

Products within the scope of the OTTC(Vehicle Type Approval)

  • Trucks • Special and specific vehicles • Motorcycles, tricycles and quadricycles
  • Buses and trolleybuses • Trailers and semi-trailers, etc.
  • Medical Registration Certificate

Registration of a medicinal product (certificate) is regulated and registered by the Federal Social Security Service – Roszdravnadzor in accordance with the “Principles for the Protection of the Health of Citizens in the Russian Federation” in accordance with the Federal Law of the Russian Federation of 09/21/2011 No. 323-FZ.

Definition of Medicinal Product According to the relevant Law

All kinds of tools, devices, devices, equipment, materials and other used for medical purposes separately or in combination with each other, together with other accessories required for the use of these products, including special products, used individually or in combination with each other are products. Manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoring, preventing or functioning in the human body by pharmacological, immunological, genetic and metabolic effects, changing the anatomical structure or physiological function of the body products.

Medicinal products can be compared in functionality, quality and technical characteristics and are interchangeable if they are interchangeable.

Medical Registration Document Process And Pricing

The classification of medical devices varies, their intended use, usage area, sterility, contents (ex: silver content), potential risks.

Classification of Medical Devices

  • Class I (Low Risk Products): Microscopes, Medical scales, Weighing, Hospital beds, Operating tables, Dental chairs, Trial glasses and prisms, Bandage and fixture fixing, General dental and surgical instruments, etc.
  • Class IIa (Medium Risk Products)
  • Class IIb (Medium Risk Products)
  • Class III (High Risk Products)

Certification of medical devices is a highly complex process that requires clinical trial protocols and performance evaluations that are reviewed and approved by the Ministry of Health Council.

Documents Required for Russian State Medical Registration Certificate

  • Application form
  • A copy of the document confirming the authorization of the manufacturer’s representative in Russia.
  • normative documents on the medicinal product (standards and / or directives regarding the product)
  • Technical file documents of the medical product
  • Instructions for use

Technical drawings of the medical device and accessories, if available

  • Documents, test reports, etc. proving the clinical efficacy and medical safety of the product.

The documents mentioned above must be in Russian or submitted with a notarized Russian translation.

  • GOST Certification

The word GOST is an abbreviation for State Standard. GOST is a set of technical standards created by the Independent State Community as a joint work of the national standard bodies of the countries and the Eurasia Standardization Council, which is a regional union. Since the establishment of the standards came from the Soviet period, a new status of these regional standards was created after the dissolution of the USSR.

Today, more than 20,000 standards are widely used in 12 countries. GOST-R certification is the first and main Russian national certification system. It determines the main requirements of this system for products in state standards. GOST-R Certificate of Conformity is a document that certifies product compliance with the safety requirements established in accordance with the standards and rules in force in the Russian Federation. The products are tested in laboratories accredited by the Russian State and a GOST R Certificate of Conformity is issued by the state-accredited certification bodies based on their reports.

However, after the dissolution of the Soviet Union, Gost processes were also established within other Eurasian Economic Community members with the establishment of national national standards. Although it is generally known as the Gost-R certificate issued for the Russian Federation, there are GOST Certification systems in Belerus, Kazakhstan, Kyrgyzstan and Ukraine, where they have regulated their own national regulations. Although the EAC system is currently in effect, Russia and other member countries still use their own standard systems for some product groups. The point to be considered here is to which country the export will be made. This document is primarily a mandatory document. It is taken to confirm the quality and safety. You can see it as a subtitle of the EAC system. It can be given once and can be given for up to 3 years.

Russian Federation – GOST-R

Kazakhstan – Gost- K

Belarus – Gost-B

Ukraine – Ukr-Sepro

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  • Explosion Proof Equipment Compliance Certificate

The Explosion Proof Equipment Conformity Certificate (Explosion Protection Certificate) is a mandatory document that certifies that properly defined equipment complies with a certain standard for some kind of explosion protection.

All explosion-proof equipment is subject to certification, including former products that are part of other equipment and installations included in Products and Services provided by the legal regulations of the Russian Federation for mandatory certification..

The basic principles of explosion safety are universal in all countries of the world. The methods used according to the basic principles The methods used for the certification of the relevant centers in Europe and the USA are based on the terms of the International Electrotechnical Commission (IEC).

Although standards in different countries have different names (Customs Union – TR TS ТР ТС 012/2011, Europe – ATEX, USA – FM), their classification approaches and methods are similar.

  • Russian Sea and River Ship Registration Certificate

Russian Sea and River Ship Registration Certificate … Certification is made for compliance with the Classification Rules and the documents ensure that the products that are certified and comply with the regulatory documents and that will not harm the life, health and property of the citizens, are of quality and safety.

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