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.
24.04.2025
03.05.2025
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)
10.02.2025
25.02.2025
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.
17.08.2024
03.09.2024
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.
28.05.2024
18.07.2024
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!
09.05.2024
18.07.2024
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?
03.07.2023
18.12.2023
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?
27.04.2021
22.06.2021
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?
14.07.2018
17.07.2018
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 you
07.04.2018
10.04.2018
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 advance
29.03.2018
29.03.2018
Please contact our office to get the answer (045 5116646). Kind regards
