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 24.07.2026 — 31.07.2026
31.07.2026
The Russian Ministry of Health will introduce additional risk indicators for state oversight of medical device circulation; The registry of permits for clinical trials of medical devices will be extended by two years; The WHO has included the Russian Ministry of Health in its list of 12 authorities to facilitate regulation of the medical device market
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News Digest 17.07.2026 — 24.07.2026
24.07.2026
The Procedure for Maintaining the Register of Clinical Trials of Medical Devices May Be Extended Until the End of 2028; Roszdravnadzor has divided the powers of licensing medical device maintenance with the regions; It has been proposed to extend the rules for labeling medical devices to multi-product sets
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News Digest 10.07.2026 — 17.07.2026
17.07.2026
Amendments to Federal Law No. 44-FZ for the procurement of medicines and medical devices have been submitted to the State Duma of the Russian Federation; The Ministry of Industry and Trade has proposed including drugs and medical devices in the new system for assessing technological leadership; The Russian Ministry of Industry and Trade intends to update the forms for certificates and declarations of conformity
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