Russia Introduced Temporary Simplified Batch Approval Process for Medical Devices for Emergency Use

On 6 April 2020, the Russian government released the Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use for prevention and treatment of coronavirus infection (including lung ventilators, oxygenators, SARS immunological and molecular assays,  sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothes).

-The Resolution #430 introduced simplified six days batch-by-batch approval process for medical devices and IVD products included in the list until the end of 2020; The new approval process will skip he current requirements for local testing according to 2n Regulation;

– Resolution #430 allows importation of non-registered medical devices and IVD products included in the list for the type testing and clinical trials without additional permits;

– Resolution #430 allows delivery/selling in Russia of non-registered single use medical devices included in the list upon condition of their disposal after 1 January 2021.

2 thoughts on “Russia Introduced Temporary Simplified Batch Approval Process for Medical Devices for Emergency Use

  1. Dear Alexey
    Thank you for the updated information. I have a question.
    If a specific series Reusable medical device acquired RC according to Resolution # 430, such as ventilator. So, after 2021.1.1, can this ventilator continue to be legally used in Russia?
    Or should be removed from the territory of the Russian Federation or destructed?

  2. According to the Resolution #430, the registration certificate will be issued with expiration date as 1 January 2021, thus after this date (if there is no changes) the registration will expire and product cannot be legal used. However there is no direct requirement in the document to remove/destruct product after this date.

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