Hello!
My question is: if the production of our company is already registered as the part of an equipment of some Russian company, do we need to get the gost certificate or other Russian certificate of quality? Or the fact, that mentioned production has already been registered as the part of the device by that Russian company, determines that all necessary procedure has already been carried out by our Russian partners and we can just export our product to Russia?
27.04.2016
04.05.2016
Hello! First of all you have to clarify about what kind of registration you are speaking. The general rule is: the spare parts of a certified product are exempt from the mandatory certification, unless they are placed on the market as products themselves. Kind regards.
For pressure equipment we have tyo comply with the new CUR 032/2013 and we facing some difficulties with the interpretation of section 54 of Annex 2. In this section it is mentioned that the safety relief valves shall be sized such that in the equipment there is no excess pressure exceeding the maximum allowed working pressure by:
A)...
B)...
C)...
Can you provide the correct interpretation of this section?
Furthermore I would like to know which pressure is to be considered as the "maximum allowed working pressure"?
Is there also a document available with explanations how to use this directive?
11.08.2014
04.03.2015
Hello, thank you for your enquiry. The CU TR 032/2013 Technical Regulation will be amended soon and it will partly clarify your questions. If you need the list of amendments, please send the request at: info@rustandard.com. The document is available only in Russian language.
So far, there are no guidelines for the application of the CU TR 032/2013. We also face some difficulties in "converting" the PS and TS of the 97/23/EC Directive into the corresponding parameters of the CU TR 032/2013. Kind regards.
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.
