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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

The SANITARY-AND-EPIDEMIOLOGIC CONCLUSION (the HYGIENIC CERTIFICATE) Rospotrebnadzor

The SANITARY-AND-EPIDEMIOLOGIC CONCLUSION (the HYGIENIC CERTIFICATE) - is the document that testifies the production's conformity to sanitary-and-hygienic norms and sanitary rules.

The Hygienic Certificate is issued after the testing of production (conditions of manufacturing, technical specifications) on the basis of the test report and the set of documents.

Validity term of the Sanitary-and-Epidemiological Conclusion Certificate, as a rule, is 5 years.


The approved List of production subject to sanitary-and-epidemiologic examination (the Order of Ministry of Health of the Russian Federation N 325 from 15.08.2001) has no precise connection with existing qualifiers: to the all-Russian qualifier of production (OKP) and customs numbers of foreign trade activities (TN VED). Therefore, often there are questions concerning the necessity of the obtaining the Sanitary-and-Epidemiological Conclusion for this or that production.

This circumstance can have unpleasant consequences for the organizations-exporters (importers) at customs registration of cargoes. Therefore we are abulutely sure that the best way to obtain this Conclusions is to turn to the professionals.

Anyhow, we can say definitely: all the children's goods, everything, that we eat, we are wearing, all the goods that we use in everyday life that contact with our leather and the food we eat, are subject to sanitary-and-hygienic certification.
There is an important nuance concerning the issuance of the Sanitary-and-Epidemiological Conclusion Certificate: in the list of production there is an Appendix # 2 and the Appendix # 3. The production, enlisted in this Appendix #2 is examinated in accredited laboratories of Rospotrebnadzor, and Ministry of Health of Russia, while the goods of the Appendix #3 is tested only in the Department of Rospotrebnadzor of the Ministry of Health. It includes various food additives, production of medical purpose (desinfection substances), all household chemical goods in aerosol package and many other things. In this case the Sanitary-and-Epidemiological Conclusion is issued on the blank of Rospotrebnadzor of the Ministry of Health of the Russian Federation.

Prices & terms for obtaining of the documents reqiured for the Hygienic Certificate depend on particular characteristics of product itself, other obtained certificates for the certifying goods and details of lab tests.

The issuance of the Sanitary-and-Epidemiological Conclusion Certificate for Appendix 2 takes from 3 to 20 days, for Appendix 3 -up to 2 months.

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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


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

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