Resolution No.804. Simplified Medical Device Registration Procedure for Prevention and Liquidation of Emergency Situations in the Russian Federation
The Resolution of the Government of the Russian Federation No.804 “On Amendments to the Special Aspects of Medical Device Circulation, Including State Registration of Medical Device Series (Batch)” has come into force on June 02, 2020.
This regulatory act is the addendum to Resolution No.430 that permits to significantly extend the list of medical devices covered by the simplified registration in the Russian Federation. See the article on our Website: www.medexpert.group for full list of medical devices.
- Certificate of Registration is valid until 01.01.2021 and issued for a series or batch only;
The applicant has a possibility to remedy any criticism of an expert institution within 5 business days;
If any batch (series) is re-registered with other lots, the applicant shall submit a dossier without any technical documentation, but with the original of previously obtained certificate of registration;
The expert institution shall consider a set of documents within three business days and send a motivated decision;
Sales of single-use medical devices unregistered in the Russian Federation are acceptable in accordance with a list stipulated in the attachment to this document, without obtaining the authorization of the Federal Service for Surveillance in Healthcare, if these medical devices have been registered in the manufacturing country in the appropriate manner;
Multiple-use medical devices imported into the Russian Federation and not registered in accordance with this document, shall be destroyed or exported from the Russian Federation after January 01, 2021.
These are the bullet points of the resolution, which we would like to draw your attention to.
It cannot be ruled out that, under conditions of the pandemic, the Government will extend the list of medical devices indicated in the Resolution.
The MedExpert team will keep you informed on all changes in the field of regulatory affairs.
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