Russian and Eurasian Regulatory Roundup of 2020

Dear Colleagues,

2021 is approaching, and in my usual December post, let me look back and summarise the highlights and major updates on medical device regulations in Russia and the Eurasian Union in the year 2020.

1. Eurasian Medical Device Regulation Highlights 2020:
   

A year ago, on 31 December 2019, the Russian healthcare regulator Roszdravnadzor announced that the first medical device was approved under the Eurasian medical device regulations. The first Eurasian registration certificate was issued for a 2A class neonatal phototherapy lamp that was manufactured in Russia.

By the end of December 2020, there have been four medical devices (in-vitro devices) mentioned in the Eurasian database – all of these manufactured by Russian manufacturers. In the same database, we can also notice over 30 files submitted for Eurasian registration between 2019 and 2020 (with a significantly high rejection rate and a review time of over 350 days).

One of the key challenges for manufacturers (especially during the time of travel restrictions imposed during the pandemic) has been the necessity for carrying out an inspection of a manufacturing site to ensure compliance with quality management system (QMS) requirements (in accordance with the Eurasian Regulation #106). This compliance, as per regulations, is a mandatory step for approval of any medical device belonging to classes IIA and III. However, in September 2020, Roszdravnadzor announced that the first QMS inspection was carried out on the first medical device and that its approval was provided by complying with the Eurasian medical device registration procedure. Roszdravnadzor also announced that it carried out manufacturing inspection of two manufacturing sites located in Russia.

Most of the 1^st, 2^nd and 3^rd level Eurasian regulations, nowadays, are released and approved by the Eurasian Commission. Some of the regulations that were updated over the course of 2020 include the amendment to the rules of registration and examination of medical devices (link in Russian), draft of a regulation on technical testing requirements (link in Russian), draft regulations on amendments to the criteria for classifying products as medical devices (link to the draft document in Russian).

According to Decision #142 (published in September 2019), the end of the transition period for submissions, according to local regulations of the Eurasian member states, as of today, still remains 31 December 2021.

2. Russian Medical Device Regulation Highlights 2020:

• During 2020, we have seen many significant developments in regulations for software as a medical device (SaMD) in Russia, which include the released updated criteria for the Russian definition of SaMD (link in Russian), and updated guidelines for registration expertise in SaMD (link in Russian), updated algorithm for the classification of SaMD (link in Russian), updated requirements for the technical file on SaMD (link in Russian) and since December 2020, we have finally noticed the implementation of the accelerated approval process (a one-step registration instead of the two-step process that was followed earlier) for SaMD in Russia.
  
• Over the course of 2020, as part of the regulatory guillotine initiative, Russia has abolished certain excessive medical device regulations, including the Regulation 12N (on adverse event reporting), Regulation 175N (on safety monitoring), the regulation on licensing of manufacturing and technical maintenance of medical equipment, the rules regarding the destruction of counterfeit medical products and other minor regulations related to medical device turnover.
  Another significant step taken has been the exclusion of medical devices from the list of products requiring a GOST certification from January 2021.
  
• 1 January 2021 marks the deadline for the procedure of the administrative replacement of the “old format” registration licenses issued before 2013. After seven years, these types of submissions will not be accepted If these registration licenses were not preplaced  in the new format, they will no longer be valid.
  
• From 1 January 2021, Russia will be implementing a new electronic process for importing samples for the purpose of medical device registration in Russia.

3. Response to COVID-19 – Russian and Eurasian Medical Device Regulations:

In the year 2020, the COVID-19 pandemic has overwhelmed the Russian healthcare system (which has been the case with other countries too). In response to the pandemic, Russian Ministry of Health introduced certain new regulatory measures and approval pathways related to medical devices and in-vitro diagnostics:

• On 18 March 2020, the Russian government released Resolution #299 (link in Russian) followed by methodical guidelines (link in Russian) and opened a simplified registration route for 36 types of class I protective medical devices, including surgical or protective face masks, respirators, medical protective clothing, surgical suits, medical gloves, overshoes, etc. The official timeline for taking a decision on registration of products that are included in the list is within five days upon receipt of the registration file, on the condition that the manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trial reports) within five months of the approval date. By the end of the year, the regulator announced that the initial registration of 1342 medical devices that were approved through the accelerated and simplified registration route were withdrawn since the required documents were not provided within the established deadlines.
  
• On 6 April 2020, the Russian government released Resolution #430 (link in Russian) followed by guidelines (link in Russian)  and introduces simplified accelerated registration process for temporary approval of particular batches of 108 types of medical devices and IVD products included in the list (this list was extended to 363 types of products )that were intended for emergency usage in the prevention and treatment of coronavirus infection.
  
• The temporary registration certificate (validity of which was prolonged until the end of 2021) of the product included in the list may be granted by Roszdravnadzor (within three business days) after carrying out testing through the special accelerated program).
  
• By the end of December 2020, there will be over 300 registration records (for particular bathes) holding a temporary registration certificate in the Russian registration database.
  
• Additionally, since April 2020, the regulator has allowed to sell imported disposable medical products included in the list (and not registered in the Russian Federation) on the condition that these products are registered in the specified manner outlined by the manufacturing country.
  
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  I would like to thank all of my subscribers and readers for showing your continuous interest and feedback  in my posts and updates. I wish you a wonderful holiday season! All the very best for the year 2021!