FAQ Gost R certification
Hello. We have currently registered our medical device in Russia under the category of "Surgical sutures" and "lifting threads." Recently, our company has undergone a name change. Please note that this is solely a change in the company name—there has been no change in the legal representative, manufacturing site address, or any manufacturing processes. According to Article 37 of Government Decree No. 1416, it appears that we may proceed with a modification of the existing registration. However, given that the regulatory framework in Russia is currently in a transitional period, we would like to confirm whether this change can still be processed as a modification, or if a new registration would be required. We would appreciate your guidance on how to proceed.Question of 24.04.2025
Hello, in Russia from 01/03/2025 the Medical Device registration and registration amendments are regulated by Govt. Decree No. 1684 of 30.11.2024. According to paragraph 111 (letter “в”) of section V, we confirm that this change can still be processed as a simple modification. The new registration is NOT required. Kind regards
we have a license for dermal filler approved under Decree 1416. but, the recently enacted Decree 1684 states that the product license registered under the previous resolution (Decree 1416) and the Rules approved by this resolution under the resolution (Decree 1684) shall be only valid until Dec. 31, 2026. Therefore, Please let me know if our license issued under Decree 1416 is valid until Dec. 31, 2026. If we apply for a new registration under decree 1684, I wonder if I can get the license for new product even if the product approval is not completed within the validity (Dec. 31, 2026) of this resolution (Decree 1684)Question of 10.02.2025
Hello, normally the Russian National Medical Device Registration has no expiry date. It is unlimited. The Russian National registration is possible (under Govt. Decree 1416 or 1684) until the 31/12/2025. The Russian National registrations obtained under Govt. Decree 1416 or 1684 can be updated until the 31/12/2026. The registration process started according to the Govt. Decree 1416 or 1684 can be completed after 31/12/2026 if started before the 31/12/2025. In other words, until 31/12/2025 you can register according the National Rules and until 31/12/2026 you can amend the National registration. If you need to update your National registration after 31/12/2026 you can’t do it, but it still remains valid and accepted. You have to make a new registration according the Eurasian Community Rules. This information is actual for today and may change in future. Kind regards
We have Class IIb product tested for all the applicable IEC testing in compliance to US FDA CE regulations. To register product at Russian Federation, we understand in country local testing required. We are looking forward to accredited test labs who can review our existing IEC reports to comply with Russian standards (GOST or other national standards) and if needed to perform supplementary testing in a Russian-accredited lab to demonstrate compliance with specific local requirements.Question of 17.08.2024
Hello, you can always contact us for more information. Kind regards
My company manufactures filters. The filter is customized. We need to apply for 032 and 010 Declaration for the filter. But i dont know how to choose the scheme, 1d,2d,3d,4d,5d.Question of 28.05.2024
Hello, it depends on what kind of filters we are talking about. All of the following may be a filter: pressure vessels, strainers (Y-filters), air filters, water filters, etc. Your request should be be more precise. Kind regards
Does alkaline battery need the Gost R Certification?Thank you so much!Question of 09.05.2024
Hello, yes, the Russian National declaration of conformity (a former GOST R declaration) is required, if we are talking about a Russian market. Kind regards
Hi there, we are the medical device manufacturer in china,mainly produce the Magnetic resonance imaging system. and my question is, we want to export our product to russia,and how can i get a MD certificate in russia? can your compney could put any service for us?Question of 03.07.2023
Hello, you can send us an inquiry by e-mail with attached MD datasheet. Kind regards
Hi There, we´re selling steam turbine to Russia and my question is, for the instruments included in the scope such as (temperature RTD PT-100, pressure gauges, vibration probes). Do these instruments have to be submitted to Russia for calibration or would I need to send the calibration certificate from the manufacturer for a Russian authority only?Question of 27.04.2021
Hello, all these instruments have to be submitted to a Russian metrological laboratory for primary calibration. Kind regards
Is POVERKA certificate is applicable for thermal relief valve to use in Russian federation?Question of 14.07.2018
Dear Sir, please refer to the Russian Federal Law No. 102 of 26.06.2008 On Assurance of Measurement Uniformity. Kind regards
Hello, Could you please explain the difference between "Poverka", "Primary Calibration Certificate", First Verification Certificate" and "Inicial Calibration - LCC" Thank youQuestion of 07.04.2018
Dear Sir, we recommend you to contact your National Metrology Center. Kind regards
Kindly Note Mr Italo Rizzi is not working anymore in this Company. I do not have your answer. Kindly answer to my question Thanks in advanceQuestion of 29.03.2018
Please contact our office to get the answer (045 5116646). Kind regards
BESIDES PROVIDING TR-CU AND RTN PERMIT OF USE, ARE YOU ALSO ABLE TO PROVIDE AN APPLICANT IN RUSSIAN TERRITORY? TO UNDERSTAND OUR PRODUCT RANGE FOR WHICH WE NEED THE WHOLE PROCESS OF EXPORT IN RUSSIA TO BE HANDLED PLEASE VISIT OUR WEBSITE www.rizzieng.com AWAITING FOR YOUR KIND FEEDBACKQuestion of 27.03.2018
Dear Sir, we already gave you (Mr. Italo Rizzi) the answer during our meeting at your office in 2013. Please, do not hesitate to contact us for further information. Kind regards
The device is a class II device. We comply with the MDD directive. IEC 60601-1 and IEC 60601-2-4.Question of 16.03.2018
Hello, the IFU in Russian language is enough since you are not a Russian manufacturer to mark the nameplate/label in Russian as well. Kind regards
We have a distributor that is telling us our product labels need to be in the Russian language. Does the manufacturer need to supply device labels in Russian? I can understand having the IFU in Russian, but the product labels needing translation is not something I have heard of before.Question of 15.03.2018
Hello, please clarify the product type and/or the applicable EU directive (if any) and/or the product standard (EN, DIN, IEC, GOST, etc.). Kind regards
We are supplying measuring instruments to a client in Russia. My question is: Can the client obtain proverka certification for the instruments when the instruments are on site in Russia, OR do the instruments need to be certified at point of manufacture before delivery to Russia?Question of 16.01.2018
Hello,
the Poverka certification can be done when the instruments are on site in Russia.
Kind regards
I would like to know if Povenka is applicable only for process measure instruments or also for instruments that are used for monitoring the mechanical status of a machinery (for predictive maintenance)and are part of the mechanical equipment (fans, pumps, compressors...). For example, vibration and temperature of bearings Thak youQuestion of 14.11.2017
Dear Sir!
The Poverka can be mandatory (see chapter 8 of OIML D 3) or voluntary, in this case it’s normally called calibration.
The mandatory Poverka is required for legal measurement instruments (see chapter 2.5 of OIML D 1) and its periodicity is specified in the Pattern Approval certificate. In case of the voluntary Poverka or Calibration, the information on such requirements should be specified in the instrument user’s manual.
Considering the above mentioned, if the “Instruments that are used for monitoring the mechanical status of a machinery (for predictive maintenance) and are part of the mechanical equipment (fans, pumps, compressors…). For example, vibration and temperature of bearings” are the measuring instruments (see chapter 3.1.4 of OIML D 1:2012) they can be subject to the mandatory or voluntary Poverka (Calibration).
Kind regards
Is pattern certificate required for valves. if "yes" then why. If "No" then whyQuestion of 28.08.2017
Hello,
if you mean Pipeline Valves the answer is NO.
If “no” then why: THE PIPELINE VALVES ARE NOT A MEASUREMENT INSTRUMENTS.
Kind regards
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.Question of 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?Question of 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.Question of 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 ESSLINGQuestion of 17.05.2017
Hello!
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 JorapurQuestion of 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 ?Question of 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?Question of 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?Question of 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 typeQuestion of 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?Question of 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.
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?Question of 11.08.2014
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.Question of 27.05.2014
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.Question of 31.12.2013
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/Question of 23.07.2013
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.Question of 07.03.2013
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 RoncelliQuestion of 12.02.2013
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.Question of 30.11.2012
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.Question of 29.08.2012
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?Question of 27.08.2012
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?Question of 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?Question of 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 LupitaQuestion of 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.