Registration of all types of medical devices

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AsiaMedConsult LLC is a team of experts with rich experience in the field of registration of medical devices of all types and risk classes.

We will help you obtain all the necessary documents to bring your product to the markets of the Russian Federation and the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia).

We value your time and guarantee fast and efficient implementation of the necessary regulatory procedures.

Registration and circulation of medical devices
in the Russian Federation and the EAEU (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia).

Prior to placing medical devices on the market of the Russian Federation and/or the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia), their quality, efficacy and safety must be confirmed through getting of registration license in these countries.
Foreign manufacturers need to take into account the specific requirements pertaining to the registration of medical devices in Russia and the EAEU countries.
The circulation of medical devices is overseen by The Federal Service for Surveillance in Healthcare (Roszdravnadzor) in Russia and by the national centers for expert evaluation under the Ministry of Health in the EAEU countries.

Why us?

Why us?

If you are looking for a reliable partner for registration of medical devices, we can offer you high-quality services, flexible individual approach to address your specific tasks, considering all your needs. Furthermore, we ensure swift implementation to meet your timelines.

Our specialists have extensive experience in marketing authorization of medical devices from top global manufacturers.

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Our specialists will review your request and answer you within 24 hours

News

News Digest 05.09.2025 — 12.09.2025
12.09.2025
The validity period of national procedures for registration of medical devices is extended by 2 years; The EEC Council clarified the rules for registration and examination of medical devices; Glucometers, tonometers, endoprostheses and reagent kits will be included in the list of labeling
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News Digest 29.08.2025 — 05.09.2025
05.09.2025
Bionic prostheses included in the "second extra" list; The schedule for creating megascience facilities and nuclear medicine complexes will change; An updated version of the domestic ECMO device Ex-Stream is getting ready to enter the market
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News Digest 22.08.2025 — 29.08.2025
29.08.2025
Roszdravnadzor has approved a new procedure for maintaining a register of clinical trials of medical devices; Changes have been prepared to the rules for marking for the purchase of medical devices; The Ministry of Industry and Trade proposed integrating the EIS and the GIS MT in terms of exchanging data on the labeling of medical devices
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