Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, April 2020

Dear Colleagues,

Here is my monthly review of medical device regulatory changes in Russia and the Eurasian region:

 

  1. Temporary Simplified Medical Device Approval Process in Russia

On 6 April 2020, the Russian government released Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use in the prevention and treatment of coronavirus infection including lung ventilators, oxygenators, immunological and molecular assays for coronavirus (COVID-19), DNA/RNA sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothing. Resolution #430 introduced a simplified six-day batch-by-batch approval process valid until the end of 2020 that skips the current requirements for local testing for the medical devices and IVD products included in the list according to the 2n Regulation and allows for temporary batch approval for these products.

In late April 2020, two Russian expert centres published guidelines/recommendations on the new approval process detailed in Resolution #430 (link in Russian) including proposed programs for type-testing and clinical trials for molecular assays and immunoassays for diagnosing coronavirus infection.

On 16 April 2020, the Russian healthcare regulator Roszdravnadzor announced the first registration certificate issued for a batch of molecular assays for coronavirus (COVID-19) manufactured by the Russian manufacturer according to newly implemented process. At the end of April 2020, there are four approved medical devices in accordance with Resolution #430 in the official medical device register database.

At the same time, regulators warned of a potential violation of the law and emphasised that circulation of non-registered medical devices and using unregistered diagnostic tests and assays is prohibited.

 

  1. Updated Medical Device Examination Requirements in Kazakhstan

On 9 April 2020, the Ministry of Health of Kazakhstan published an updated version of Order #736 ‘On rules on expertise of medicines and medical devices’ (link for updated document in Russian) and enforced the following amendments for the medical device approval process in Kazakhstan:

  • Requirements have been significantly simplified for the required laboratory testing before the registration of medical devices: henceforward, the testing is not required for renewals of current registrations nor for the registrations of active (electric-driven) medical devices and medical devices approved in the European Union, USA or Japan;
  • A new accelerated registration path has been implemented for cases of emergency and for manufacturers with ISO 13485:2016 certification from European Notified Bodies that have agreements with the Kazakhstan Ministry of Health;
  • Requirements for onsite testing have been updated: onsite inspection is required for registration when samples require special conditions for transportation or require special testing methods. At the same time, based on data from the documents, local laboratories may confirm some characteristics without inspection;
  • The sequence of the steps for obtaining medical device registration expertise has been changed: henceforward, the steps are initial examination, specialised stage and laboratory testing. However, there are still three steps and overall timelines remain unchanged.

Later, on 21 April 2020 the Kazakhstan National Center of Expertise of Medicines and Medical Devices updated information on registration and re-registration fees according to the new approval procedure.

  1. Statistics on Medical Device Approval in Russia for 2019

On 21 April 2020, Russian healthcare regulator Roszdravnadzor published the annual report with statistics on medical device registration in Russia for the year 2019. According to the published document, in the last year, 1469 medical devices were approved (39% for Russian and 61% for international manufacturers). The number of registration rejections last year slightly decreased (by around 12%) compared to the year before.

The regulator also reports about 3329 inspections were conducted that revealed more than 4000 nonconformities and 47 medical devices were restricted from circulation in Russia based on post-market monitoring over the last year. One medical device had been approved according to the Eurasian registration procedure. There are no updates to this number as of the end of April 2020).

 

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I would like to thank LIMI Consulting who helped me with the information regarding updates to Kazakhstan regulations in this post. Let me also remind you that you can receive monthly Russian medical device regulation updates directly to your email via the ‘follow’ button on the toolbar of this blog.

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