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.

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.

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.

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

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 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

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.

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 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.

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.