RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN
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What are the total registration fees for medical devices? 24.07.2012

Hello! The fee for the issue of 1 Medical Device Registration Certificate from 01/01/2013 is 6.000 rubles (approx. 200 USD). The cost of the laboratory test may vary from device to device and its class of risk. The required tests are: biocompatibility and toxicity, EMC, general safety, clinical trials. Each test costs approximately 1.000 - 1.500 USD. Document translation and notary fees 1.500 - 2.000 USD. The overall cost of the registration may vary from 8.000 to 25.000 USD. 

Are phthalates (found in pvc) restricted on any items for import into Russia? Where could I get a list of the specific phthalates (and levels allowed)? What types of certificates would need to be applied for to import a clothing/accessory item with phthalates? 16.05.2012

Hello! You can find the answers to your questions in the Uniform Sanitary and Epidemiological and Hygienic Requirements for Goods Subject to Sanitary and Epidemiological Supervision (Control) approved by the Decision of the Customs Union N 299 of May 28, 2010.

Hello: Could you please confirm If Hygienic Conclusion is necessary in Russia yet? Or if it has been replaced by other document. Thanks in advance Lupita 02.02.2012

Hi! Thank you for your enquiry. The Russian National hygienic conclusion certificate (i.e. expert report) has been partially abolished from 01/07/2010, and partially substituted by the Customs Union expert report and the Customs Union hygienic registration certificate.

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