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 21.11.2025 — 28.11.2025
28.11.2025
EAEU regulations will expand the permissible cases for the circulation of unregistered medical devices; The Government Expanded Risk Categories for Medical Device Inspections; The government has clarified the labeling parameters for disposable technical rehabilitation devices
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News Digest 14.11.2025 — 21.11.2025
21.11.2025
Roszdravnadzor has developed regulations for issuing extracts from the state register of medical devices; Roszdravnadzor has changed its decision on vending machines; Evgeny Nifantyev proposed measures to prevent the sale of uncertified medical devices on marketplaces
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News Digest 07.11.2025 — 14.11.2025
14.11.2025
Russia to Launch Post-Market Quality Monitoring of Urological Medical Devices; The Moscow Department of Health has included medical devices and therapeutic nutrition products in its regulations for the use of electronic prescriptions; Expanding the "second-odd-person" rule could increase healthcare facilities' costs
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