RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN
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For a client we have to supply Primary state calibration certificates for instrumentation. Is this a mandatory requirement according to the russian regulations when we supply instrumentation to Russia? pl. note that we are not an instrument manufacturer. 27.05.2014
05.06.2014

Dear Sir,
the Primary state calibration certificate is required in order to employ the measuring instruments within the fields covered by the State metrological control and supervision in the Russian Federation. It must be provided by the supplier if it was mentioned in the contract.
Kind regards.

we are manufacturing Reactor for our client TAIF-NK,Russia. We require TR Cu certificate. We will supply 6 reactor (All have different sizes) in June-2014 to July-2014. (1) Kindly confirm TR CU 010 Or TR CU 032 is applicable for our type of equipment. (2)Also confirm 1d scheme or 2d scheme is applicable for our type of equipment. Also send your best suitable offer. 31.12.2013
15.01.2014

Hello, thank you for your enquiry.
If you refer to the Reactors according to EN 13445-2002: 1. The CU TR 010/2011 and CU TR 032/2013 are applicable. 2. The schemes 1d or 2d are not applicable. We work only with Italian companies and unfortunately can’t help you.

What regulations cover infant products such as high chairs, playpens, cradles, srollers and similar infant products/ 23.07.2013
24.07.2013

Hello, you have to refer to the Customs union Technical Regulation “On safety of products intended for children and teenagers” (CU TR 007/2011).

If register a Medical device in Russia, whether Russian regulation stipulates that the product must be first approved by the Health Authority in country of origin? Thank you. 07.03.2013
12.03.2013

Hello! The basic requirement to register a medical device in Russia is that the manufacturer must be certified ISO 9001 and/or ISO 13485. The prior approval of a medical device by the Health Authority in country of origin is not a mandatory requirement, but if the medical device has already been approved as a medical device in the country of origin, some test can be avoided in Russia.

Dear All, Id like to ask you what are the steps/procedures/documentation required in order to register our medical devices. In particular, are devices for "carboxytherapy" used for the treatment of adiposity, improvement of microcirculation and many other positive effects. These devices are produced entirely in Italy: design, materials used (own brand), assembly. At your disposal for any other information you required to better detail your reply about it. Thank you and best regards Carlo Roncelli 12.02.2013
12.03.2013

Dear Mr. Roncelli, thank you for your enquiry. Please find in the following file the updated information with the answers to your questions: http://www.rustandard.com/images/schema-iter-dispositivi-medici.pdf

An Inidan company is supplier of light industry products for childred, juvenile and adults of garment and woven knitted products from textile materials, leather and fur to a Rusain company which imports garments and footwear. Please let me know if a contract of agency is requied to be executed between the indian and russian company as per technical Regulaions of customs union. If yes, is it mandatory. 30.11.2012
12.03.2013

Hello! According the CU TR 007/2011 On Safety of Products for children and adolescents, Article 12. Conformity assessment (confirmation) and the CU TR 017/2011 On the safety of light industry products, Article 11. Conformity assessment (confirmation), the applicant for the certification or holder of the declaration of conformity can be: Agent (the Manufacturer’s Representative), established on the territory of the Customs union, on the basis of a written contract or the Importer, legal or physical entity established on the territory of the Customs union, on the basis of a written contract or invoice (for a single shipping). Yes, it is mandatory.

When the packaging and/or components of a medical device change, does a company have to re-register the new medical device and obtain new certificates ? Thank you Debra Leeves General Manager Avita Medical Ltd. 29.08.2012
12.03.2013

Hello, thank you for your enquiry. If the components of the medical device change the new registration certificate is required for such components or the existing certificate must be updated. As regards the packaging, is it hard to respond you since we need more information about what does exactly change.

Dear Sirs, We are maufacturer of PPE Personal Protective Equipment as Fall Arrest Equipment agaist falls i.e. Safety Harnesses, Lanyards, Anchor lines etc. Products are scertified to EN standards and CE marked. We have been contacted bu users of our equipment that is going to work in Ucraine, the question is they allowed to use CE marked product? 27.08.2012
12.03.2013

Dear Sir, thank you for your enquiry. Yes, the CE marked products are admitted on the Ukrainian market, but you will have to obtain the local certificates as well. If the products are imported for personal use no certifications are required.

What are the total registration fees for medical devices? 24.07.2012
12.03.2013

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
12.03.2013

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.

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