Product certification in the Russian Federation and the EAEU
For manufacturers
For importers
FOR EXPORTERS
All certificates and declarations are issued in accordance with the unified standards of the Customs Union and are valid simultaneously in Russia, Belarus, Kyrgyzstan, and Kazakhstan.
We will prepare documentation for inclusion in the register of the Ministry of Industry and Trade
We will create a product catalog in the GISP system
We will complete the examination by the Chamber of Commerce and Industry
5
years
with experience from
received certificates, permits
with payment for results
over
100%
sets
500
Team of professionals
GUARANTEE
CERTIFICATION
LICENSING
INCLUSION IN THE REGISTER OF THE MINISTRY OF INDUSTRY AND TRADE
STATE REGISTRATION CERTIFICATE (SGR)
INSPECTION, EXPERTISE AND TESTING SERVICES IN HEALTHCARE
VEHICLE TYPE APPROVAL (VTTA)
LEGAL SERVICES FOR FACTORIES AND ENTERPRISES
CustomS broker services
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What we are strong in
Enter the name of your product
We will prepare comprehensive information about the documentation required for it in the EAEU zone, as well as the timeframes for obtaining it.
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Sending / receiving a request
Meeting or phone call
We discuss the tasks and expected outcome
Task completion
Signing the contract
We make a calculation and provide a commercial offer
Price/terms
The process of interacting with you
With minimal involvement on your part we will ensure inclusion in the register of the Ministry of Industry and Trade of the Russian Federation.
We will assist in obtaining certification in accordance with the Technical Regulations of the Customs Union and national standards of the Russian Federation.
We will develop technical documentation;
STAGES OF THE PROCESS OF INCLUSION IN THE REGISTER OF THE MINISTRY OF INDUSTRY AND TRADE
We guarantee confidentiality
Before consulting and reviewing your documentation, we will sign a non-disclosure agreement.
Approval of the terms of reference with the customer — including nomenclature, technical characteristics, OKPD2 and HS codes, analysis of regulatory documentation, presence or absence of declarations and/or certificates for products, materials used, production status, and production equipment.
Issuance of an electronic digital signature (EDS), if not available
Registration and setup of your personal account in the GISP system
Confirmation of the EDS
Approval of the information to be entered in the "GISP Product Catalog"
Filling out the catalog (with EDS), checking, validating, and moderation by specialists from the Ministry of Industry and Trade
Registration and setup of your personal account in the GISP system
Confirmation of the EDS
Approval of the information to be entered in the "GISP Product Catalog"
Filling out the catalog (with EDS), checking, validating, and moderation by specialists from the Ministry of Industry and Trade
Collection, verification, and coordination of documents according to the requirements of the CCI:
Copy of the charter
Copy of the executive appointment order
Copy of the information letter from Rosstat indicating the OKPO code
Copy of the extract from the Federal Tax Service
Information on employee equipment
If necessary, development of technical specifications and registration of certificates
Copy of the charter
Copy of the executive appointment order
Copy of the information letter from Rosstat indicating the OKPO code
Copy of the extract from the Federal Tax Service
Information on employee equipment
If necessary, development of technical specifications and registration of certificates
Creating an application in the GISP system by uploading the prepared documents:
"Application" on behalf of the Manufacturer / Applicant for an Expert Report or ST-1 Certificate with an expert opinion, along with a package of documents and the appendix "Inventory of Documents Provided".
"Application" on behalf of the Manufacturer / Applicant for an Expert Report or ST-1 Certificate with an expert opinion, along with a package of documents and the appendix "Inventory of Documents Provided".
Support during the CCI examination:
Monitoring each stage of the process; making adjustments and providing missing information if necessary
Support during the on-site examination at the enterprise
Monitoring each stage of the process; making adjustments and providing missing information if necessary
Support during the on-site examination at the enterprise
Submission of an application to the Ministry of Industry and Trade to obtain a conclusion confirming the Russian origin of products, with the relevant documents attached.
Entry into the register in the GISP system of the Ministry of Industry and Trade.
Entry into the register in the GISP system of the Ministry of Industry and Trade.
Our customers
Contacts
Representative Office
SAINT PETERSBURG Moscow region
VILNIUS,
11114 Vilnius city municipality Arima 18
11114 Vilnius city municipality Arima 18
MOSCOW, highway Enthusiasts, house 82/2, building 1, floor 2, room 1
Representative Office
Head office (Moscow)
News
© UNIMAX Group LLC, 2024
OGRN 1137746241555
TIN 7722803779
Healthcare Inspection, Examination, and Testing Services
Center for Expertise and Testing in Healthcare
- Examination of documentation for the state registration of medicinal products and pharmaceutical substances
Medicinal Products and Pharmaceutical Substances
- Examination of documentation for the possibility of obtaining import permits for unregistered medicinal products (pharmaceutical substances) restricted for movement across the customs border of the Republic of Belarus on non-economic grounds, including those received as foreign gratuitous aid
- Examination of documentation and issuance of conclusions for the approval of clinical trials of medicinal products conducted by contract research organizations
- Examination of amendments to protocols of multicenter clinical trials of medicinal products conducted by contract research organizations
- As part of the registration process of medicinal products and pharmaceutical substances: testing of methods for quality control of medicinal products and pharmaceutical substances
- Quality control of medicinal products registered in the Republic of Belarus in accordance with national regulatory legal acts governing medicinal quality control
- Examination of documentation for the issuance of permits for the import and/or export of narcotic drugs, psychotropic substances, and their precursors restricted for movement across the customs border of the Republic of Belarus on non-economic grounds
Narcotic Drugs, Psychotropic Substances, and Their Precursors
- Preparation of documents for obtaining licenses from the Ministry of Health for the import and/or export of narcotic drugs, psychotropic substances, their precursors, human organs and tissues, blood, and its components
Medical Equipment and Medical Devices
- Organization and implementation of state registration (or re-registration) of medical equipment and medical devices
- Examination of documentation for permits for the sale and/or medical use of unregistered medical devices and medical equipment
- Examination of documentation for conclusions verifying whether imported goods are medical devices, medical equipment, or raw materials/components for their production (for VAT exemption); confirmation of the intended purpose of imported goods (for customs duty rate determination)
Information Services and Advertising
- Approval of advertisements for medicinal products, methods of medical care, services and works constituting medical activity, medical products, medical equipment, and dietary supplements
- Provision of information services
Gosfarmnadzor Services
Medicinal Products and Pharmaceutical Substances
- Inspection services for pharmaceutical manufacturing compliance with Good Manufacturing Practice (GMP) requirements of the Eurasian Economic Union
OBTAINING A REGISTRATION CERTIFICATE FOR MEDICAL DEVICES
Full service (documentation, dossier preparation, testing, and support in Roszdravnadzor) — from 290,000 RUB
Federal Service for Surveillance in Healthcare
Certification process
HACCP CERTIFICATION
HACCP Certification Development, Implementation, Audit, and Obtaining International Certificate — from 60,000 RUB
ТР ТС 010/2011
Certification and testing
Certification of Machinery and Equipment – TR CU 010/2011
Certification and testing
Certification and Testing of Cable Products – TR CU 004/2011
Certification of Elevators – TR CU 011/2011
Certification and testing
Certification and testing
Certification of Explosion-Proof Equipment – TR CU 012/2011
Testing by Accredited Testing Centers
(Locomotives; motor-car rolling stock and its cars; locomotive-hauled passenger cars; freight cars; special railway rolling stock; railway rolling stock and its components)
Testing of Railway Products – TR CU 001/2011
Certification of Wheeled Vehicles and Components – TR CU 018/2011
Certification and testing for wheeled vehicles of categories L, M, N, and O intended for public road use; chassis; and vehicle components that impact vehicle safety
Voluntary Certification – TR EAEU 043/2017
Certification of Technical Equipment Capable of Emitting Electromagnetic Interference and/or Whose Functionality Depends on External Electromagnetic Influence – TR CU 020/2011
Certification and testing
ISO Certification Voluntary — from 9,000 RUB Mandatory — from 85,000 RUB
ISO CERTIFICATION
INCLUSION OF PRODUCTS IN THE REGISTER OF THE MINPROMTORG
Collection, registration, and approval of a package of documents with the Chamber of Commerce and Industry
Collection, registration, and approval of a package of documents with the Chamber of Commerce and Industry, filling out the GISP catalog, obtaining ST-1 / expert report (turnkey service)
Registration of the production fund, specifically the opening of a new production branch; collection, registration, and approval of a package of documents with the Chamber of Commerce and Industry, filling out the GISP catalog, and obtaining an ST-1 / expert report
(Russian Federation, Kyrgyzstan, Armenia)
CERTIFICATE OF STATE REGISTRATION
Collection of a package of documents, testing:
For the import of controlled products into the territory of the Customs Union
For issuing certificates and declarations of conformity for a number of goods in accordance with the requirements of certain technical regulations of the Customs Union
To be submitted to retail stores, retail chains, partners, and government supervisory authorities
For participation in tenders
For issuing certificates and declarations of conformity for a number of goods in accordance with the requirements of certain technical regulations of the Customs Union
To be submitted to retail stores, retail chains, partners, and government supervisory authorities
For participation in tenders
EXPORT OF GOODS / IMPORT OF GOODS (CUSTOMS BROKER SERVICES)
Customs clearance of procedures of any complexity, registration of permits, support of deliveries, representation of the declarant’s interests, organization of phytosanitary, veterinary, and sanitary quarantine control, storage and operations with goods in a customs warehouse, payment for goods and acceptance of funds in any currency, logistics.
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