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Registration and Certification of Medical Products (medical equipment) in the Russian Federation and Republic of Kazakhstan Industrial Expertise and Obtaining of the Permission of Rostekhnadzor (RTN) of the Russian Federation for application of technical devises (equipment) GOST-R. Certification Contacts About company

Facility

Conformity assessment

Certification of production in System of GOST-R

Obligatory Certificate of Conformity for 3 years

Obligatory Certificate of Conformity for 1 year

Obligatory Certificate of Conformity delivery (contract)

Voluntary Certificate

Exemtion Letter

Declaration On Conformity

Certificates Licenses

Pattern_Approval Certificate for measuring instruments

Sanitary-and-epidemiologic conclusion (the Hygienic Certificate)

Obligatory Certificate of Conformity of GOSSTROY (State Construction) of the Russian Federation

Emercom Certificate of fire safety

Certificate of Conformity of the Ministry of Communications of the Russian Federation (the Certificate of the Communication Facility)

Registration Certificate of Iatrotechnics, products of medical purpose, medical products and new medical technologies Rosdravnadzor (Health Control) of the Ministry of Health of the Russian Federation

Certificate on the State Registration of Biologically active additives to food ROSPOTREBNADZOR (Consumers' Control) of the Ministry of Health of the Russian Federation

The Certificate On the State Registration Disinfectant, Desinsection And Deratisation Means of ROSPOTREBNADZOR Ministry of Health of the Russian Federation

GOST-R. Certification of all kinds of products imported to the Russian Federation and the Republic of Kazakhstan

Do you want to sell your products in Russia and Kazakhstan directly or via your distributors' network?

What does a product Supplier to Russia and Kazakhstan need to know?

1. Russian currently valid standards differ from the international standards ISO, IEC, ITD and the European ones - CEN, CENELES, ETSI in some aspects (see illustrations of certificates)

2. This means that to export products to Russia and Kazakhstan a supplier needs to get the obligatory certificate of conformance GOST R:

- for a contract or a lot

- for a product maker for a period of one year
or
- for a product maker for a period of 3 years

3. Moreover, there are some industrial requirements for products in the Russian Federation made by different ministries and authorities. This means that in addition to the obligatory certificate of conformance GOST R the following permissive documents will be necessary:

- Fire Safety Certificate;
- Certificates of Gosstroy (State Committee for Construction and Housing and Utility complex);
- Certificates of Conformance for Weighing and Measuring Devices;
- Certificates of Conformance for Communications Facilities;
- Sanitary-and-Epidemiological Conclusions (Hygienic Certificates);
- Registration Certificates of Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development of Russian Federation) for:

a) medical products (medical supplies and equipment);
b) drugs and pharmaceutical substances;
c) medical technologies;

- Registration Certificates of Rospoterbnadzor (Russian Federal Consumer Rights Protection and Human Health Control Service) for dietary supplements, biologically active supplements, tobacco, mineral water and drinks;
- Explosion Safety Certificates;
- Certificates of Rosselkhoznadzor (the Russian Federal Service for Veterinary and Phytosanitary Surveillance) for feed and medicinal supplements;
- licences of Rostekhnadzor (the Federal Service for Environmental, Technological and Nuclear Supervision) for application of technical devices (equipment);
- voluntary certificates;
- licenses, expertises, assessments and other types of documents.

What advantages do you get contacting us?
The group of companies of our consortium will provide you with:

- a unique chance to get a complex solution of all questions and may be problems connected with product/service promotion to Russian and Kazakh market;

- we will arrange a complete list of permissive documents (Certificates, Licenses, Permissions and others) which will be necessary for you to export any kinds of products to Russia and Kazakhstan.

- all documents will be executed in accordance with current legislation and normative-legal base of the Russian Federation and Republic of Kazakhstan.

- we will consult you on questions connected with customs' registration of loads and offer you our help in transporting your products to the territory of Russia and Republic of Kazakhstan;

- at your request we will carry out marketing researches (we will determine the price level, the product competitive ability etc.);

- we will provide you with all necessary information about exhibition activities, forums, contests and tenders for products and equipment purchasing taking place in Russia and its regions.

- we will help you to identify the product code according to TN VED (The National Classification of Goods), to audit a buyer company or a product supplier.
Working with us you get the following advantages:

- decrease of time period for product entering the Russian market;
- decrease of risks;
- increase of sales volume;
- getting a reliable partner;
- decrease of organization and financial expenses;

- our experts and consultants will provide you with on-line support,

- all documents will be sent to you by express delivery (DHL,THT);

- we receive all necessary certification documents in your language and translate them into Russian;

- we perform product tests and examinations quickly and properly in accredited test laboratories and certification bodies of our consortium;

- we will execute all documentation necessary for you in accordance with your confidence in any Ministry and authority of executive power of the Russian Federation, we will obtain all necessary documents for your product;

- all services provided by us are carried out strictly confidentially and on a high professional level.

Conformance certificate GOST R is a perfect marketing instrument for attracting a Russian buyer.

Timing of works on documentation execution:

a) timing for execution of Voluntary Certificates, Exemption Letters, Conformance Claimants, Sanitary-Epidemiological Conclusions, Mandatory Conformance Certificates of Gosstroy, Fire Safety Certificates is from two to twenty days.

b) timing for execution of Conformance Certificates of Ministry of Communications of Russia, Permissions of Gostekhnadzor, Certificates of Conformance for Weighing and Measuring Devices, Registration Certificates for Medical Equipment and products, Sanitary-Epidemiological Conclusions, Registration Certificates of Rospoterbnadzor of Russian Public Health Ministry for dietary supplements, State Registration Certificates of Rospoterbnadzor of Russian Public Health Ministry for Disinfectant Means is from 1.5 to 3 months.

c) timing for execution of Registration Certificates for medicaments, pharmaceutical substances and new medical technologies is from 6 months to 1 year.

The first step to work with us:

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Standardization,
certification and metrology

The national organizations

The international organizations

ISO WTO ASEAN

Normative and legal base of
the Russian Federation In the
field of certification:

Decrees of the President

Resolutions
of the Government

Russia (Moscow)
PromExpert Group +7 495 795-94-10
+7 495 795-94-06
info@promexgost.com PromExpertGroup
Germany (Monchengladbach)
PromExpert GmbH +49 2161 498-67-33
info@promexgost.com

The 1st step to work with us: To get information about the exact prices and terms of executing and obtaining documents for your product

fill in
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