RUSTANDARD - Product Registration and Certification
GOST R, Gost Russia, Gost Standard, RTN, GGTN
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Is it required to get a special permit to import medical device samples not intended for human use and not intended to be sold? If no import permit required, is there any special labelling needed? The samples will be used for training and demonstration to customers. Thank you. 09.08.2017

Hello, in your case the import permit and/or any special labelling are not required.
We also inform you that according to Article 7, point 5, of the Russian Federal Law of 13.03.2006 No. 38-FZ "Law on Advertising" it is prohibited to advertise goods subject to state registration which have not been registered. Kind regards

Who can issue a Proverka for calibration certificates issued by the manufacturer. We are a A2LA accredited Calibration Lab to ISO IEC 17025, are we allowed to issue the Proverka? 08.08.2017

Hello, the Mandatory periodic verification certificate (terms and definitions according to the chapter 9 of OIML D 3:1979  / aka "Poverka certificate") in the Russian Federation can be issued only by the metrological laboratories accredited within the Russian National Accreditation System (Decree of the Ministry of Industry and Trade of the Russian Federation No. 1815 of 02.07.2015). Kind regards

In Gost R 21.1101, what does SPDS stands for? I'm trying to get the acronym but couldn't find it. Many thanks in advance for your reply. 15.06.2017

Hello, the SPDS is the acronym in Russian language of a family of standards which in English stands for "System of design documents for construction". Kind regards.

Dear, "only for the measurement instruments covered by the Legal Metrology rules" What is your defintion of Legal Metrology rules. Thanks in advance Thierry ESSLING 17.05.2017

For the definition of term Legal Metrology, please refer to the Section 2.5 of OIML D 1:2012. Regarding the areas, covered by the Legal Metrology in the Russian Federation, see the Article 1, Clause 3, of the Federal Law No. 102-FZ of 26.06.2008.
Kind regards

need some details on Primary Verification Certificate and what is the procedure to obtain the same. We need to supply some temperature transmitters which are already having TRCU document. Regards, Sagar Jorapur 21.04.2017

Hello, as for the Primary Verification Certificate, please refer to the Chapter II, Article 5, of the OIML D 3:1979. As for how it happens in Russia, please refer to the Decree of Ministry of Industry and Trade of the Russian Federation No. 1815 of 02.07.2015. Kind regards

Primary calibration certificate and Metrology(pattern approval) certificate are the same thing or it is different ? Both are compulsory requirement for supplying the instrument in Russia ? 07.10.2016

Dear Sir, the Primary Calibration certificate and the Metrology (pattern approval) certificate are two different documents. Both are compulsory in Russia only for the measurement instruments covered by the Legal Metrology rules. Kind regards.

A Russian customer wants Primary Calibration Certificate for some instruments, but since i am working in Europe how can i supply it to him? Only Russian companies can apply for it, right?I have to order the instrument with this certificate from a Russian company? 16.08.2016

Hi, a foreign company can also apply for it.

Hi, we have to supply different process analyzers with Primary Calibration Certificates. The question is : this certificates migth be issued by the analyzer's manufacturer or they must be released by any Russian Accredited Laboratory? 02.08.2016

Hello, the Primary Calibration Certificate of the measurement instruments covered by the Legal Metrology rules can be issued only by the Russian State Legal Metrology Laboratories (see the Russian Government Resolution No. 250 of 20.04.2010). The Primary Calibration Certificate of all other measurement instuments can be issued by any Russian Metrology Laboratory, who has the measurement instruments to be calibrated within its scope of accreditation. A foreign manufacturer can't issue the Russian Primary Calibration Certificate any more.

A customer is requesting a primary state calibration certificate for our instrument. Is this primary state certificate a document for each individual produced instrument or a certificate which is valid for the instrument type 11.05.2016

Hello! According to the Decree No. 1815 of 02.07.2015 of the Ministry of Industry and Trade of the Russian Federation (Minpromtorg), the Primary Calibration Certificate is required for each individual produced measurement instrument to be used in the Legal Metrology field. Kind regards.

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

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.

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