Three Things You Should Know about Medical Device Regulations in Russia, May 2020


Dear Colleagues,

Here is my usual selection of highlights to keep you in the loop regarding updates in Russian medical device regulations:

  1. Accelerated medical device approval tracks in Russia

As you are probably aware from my previous updates,  two accelerated pathways for approval of medical devices were introduced in Russia in response to the coronavirus pandemic over the last few months:

  1. An accelerated track for 36 types of low class medical devices included in the list under Resolution #299 (link in Russian).
  2. Accelerated track for particular batches  for 108 types of medical devices and in-vitro products intended for emergency use in the prevention and treatment of coronavirus infection. The relevant devices are listed under Resolution #430 (link in Russian).

As of 29 May 2020, according to the official database of registered medical devices , there are at least 48 assays for diagnostics of coronavirus infection (molecular assays for detection of the virus and immunochemistry assays for antibody detection) approved in Russia (both accelerated approval for particular and normal registration process; both Russian and foreign manufacturers included).

On May 2020 Russian regulators suggested expanding the list of medical devices appropriate for accelerated pathways.

  1. Restrictions on the procurement of medical furniture, certain protheses and orthopedic devices

On 30 April 2020 the Russian government published Resolution #617, ‘On restrictions on the admission of certain types of industrial goods originating from foreign states for the purpose of procurement to meet state and municipal needs’ (link in Russian). The document introduced a list of goods originating from foreign countries including medical furniture, protheses and certain orthopedic devices which are subject to restrictions for state and municipal procurement. Products in the list are subject to the ‘third odd one out’ rule which states that the public procurement process must exclude foreign manufacturers if at least two bids from local (Eurasian) manufacturers are submitted for tender.

It should be noted that the list of industrial goods introduced by Resolution #617 , a similar list of medical devices was introduced in Russia in 2015 under Resolution #102 (link for current version of the in Russian).

3. Updated risk indicators for control on medical devices

On 8 May 2020 the Russian Ministry of Health published a draft document, ‘On the approval of risk indicators <…> in the field of circulation of medical devices to be used as the basis for unscheduled inspections …’ (link in Russian).
The document sets out four indicators that may be used reasons for the regulator to initiate an unscheduled inspection/audit of medical device manufacturers and their representatives/distributors.

Suggested indicators include:

  • Discrepancies in information about medical devices published in the media with information submitted for registration.
  • Information revealed concerning a potential threat to human life or public health for a medical device registered in Russia that has been published by international regulatory agencies but not reported to the Russian competent authority.
  • Two or more warning notices regarding violation of the medical device regulations have not been replied by the manufacturer.
  • Information on a violation during pre-registration testing or clinical trials obtained by the regulator from monitoring the media.

To be recalled that risk indicators were introduced in November 2019 under the Russian medical device regulation, Resolution #1433 (link in Russian) and a previous version of the indicator list was published in January 2020.

According to Resolution #970 on the state control of medical devices, the Russian healthcare regulator Roszdravnadzor performs regular planned and unplanned inspections of medical device manufacturers and their representatives.

2 thoughts on “Three Things You Should Know about Medical Device Regulations in Russia, May 2020

  1. Dear Alexey,
    Thanks for this update on the Eurasian Regulation.
    It is still not clear for me what is going to be the status of the current valid registration certificates in Russia. If we have a registration certificate (class IIa – no expiry date) obtained in 2018, will it become void for use in Russia after 12/2026?
    Looking forward your reply.
    Best regards
    Natalia

  2. Hi Natalia,

    My understanding is the following:
    -According to the Decision of the Eurasian commission #142 (https://docs.eaeunion.org/docs/ru-ru/01422901/clco_05092019_142) clause 2: the registration certificates issued before 31/12/2021 may be on the market until the end of the validity date of the certificate i.e. in your case it will remain void in Russia even after 12/2026;

    -Please note that Russian regulation require update the registration dossier in case of any change in technical file or instruction for use; if any change happen, my understanding, according to the Decision #142 that you may submit renewal under the Russian rules until 12/2026;

    -If change of your dossier happen after 12/2026, according to the current regulation, you will not able to update the licence according to the Russian regulations, and will need to submit for Eurasian registration.

    Hope it make sense,
    Regards,
    Alexey

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