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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

DECLARATION OF CONFORMITY

The Declaration Of Conformity is made out according to the List of production approved by the Government of the Russian Federation. This list includes: accumulators, photoobjectives, note-books, wall-papers, sugar, bakery products and other goods.

The Declaration Of Conformity, in other words, GOST R Declaration, is filled under the established form.

The Supplier of goods must have the proofs of conformity.

These proofs are:

- the test reports of production arranged by the Exporting company or foreign accredited test laboratories;

- certificates of conformity or test reports on raw material and completing products;

- The documents stipulated for this type of production (the sanitary-and-epidemiologic conclusions, veterinary certificates, certificates of fire safety, etc.);

- certificates, confirming the system of quality, as well as other documents directly or indirectly assuring the conformity of production to the existing requirmments.

The Declaration Of Conformity accepted by the supplier is a subject to registration in the accredited Body of Certification. The Declaration's registration number includes a code of this body.

The registered Declaration Of Conformity is the basis for marking production with a sign of conformity.

The Declaration Of Conformity is made out in Russian, usually its validity term is 3 years .

The form of the GOST R Declaration is approved by federal body of executive authorities, responsible for the technical regulation.

The Declaration Of Conformity is to be registered by federal body of executive authorities, responsible for the technical regulation within 3 days.

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

It takes from 2 to 20 days to obatain the Declaration Of Conformity.

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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


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