Welcome to my monthly review of the most important updates to medical device regulations in Russia and the Eurasian countries.
- Development of the Regulations for Software as a Medical Device (SaMD) and Artificial Intelligence
On the 10th August 2020, the Russian Ministry of Health published order #686N (link in Russian) and updated the algorithm for the classification and registration of SaMD.
In addition, in early August 2020, the Russian Ministry of Health published two draft regulations:
- An amendment to the rules governing the state registration of medical devices (link in Russian) suggesting an accelerated approval process (a one-step registration instead of the current two-step process) for SaMD, including software that uses ‘artificial intelligence technologies’.
- An amendment to the requirements for technical files and the instructions for their use (link in Russian), providing specific requirements in relation to the technical files for SaMD.
It is interesting to mention that at the end of July 2020, the Russian Ministry of Health announced that work to improve the standards of artificial intelligence in healthcare was underway, and in the last month it has been revealed that a first draftof the national standard on clinical trials for systems with artificial intelligence has been published.
Regular readers might also recall that in June 2020, the Russian healthcare regulator Roszdravnadzor published the updated guidelines (national methodical recommendations) for the registration of SaMD in Russia (link in Russian).
The accelerated approval process for the registration of low-risk medical devices (class I) and in vitro diagnostics was implemented in Russia in 2018.
- List of Medical Devices Containing Ethyl Alcohol
On the 26th August 2020, Roszdravnadzor published (link in Russian) a list of 41 medical devices containing ethyl alcohol that are excluded from general alcohol regulations in Russia, such as Federal Law 171. The production, importation and circulation of these products will not be covered by the federal law on the regulation of ethyl alcohol and thus will not require additional licenses or permits.
According to the current procedure, this list is created using applications from manufacturers, or their authorized representatives, submitted to Roszdravnadzor between the 1st of January and the 30th of June each year, and subject to rules that came into effect in 2019.
It should also be noted that Russian legislation specifies that any medical device in liquid form containing ethyl alcohol (ethanol) should be subject to additional specific regulation.
- Eurasian Update
On the 3rd August 2020, the Eurasian Commission published a draft regulation with an amendment to the rules for toxicology (biocompatibility) testing of medical devices for Eurasian registration (link to the draft in Russian).
This document included updates to the testing requirements and the description of the testing procedure. The regulation also updated the criteria for the inclusion of testing laboratories into the unified Eurasian database.
For the end of August 2020, according to the official website of the Eurasian Commission, there were three medical devices approved using the Eurasian procedure with more than 20 applications for Eurasian registration submitted by manufacturers over the last year, and 23 laboratories now accredited to perform the testing.
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