Three Things You Should Know About Medical Device Regulations in Russia and the Eurasian Union in May 2021

Dear Colleagues,

Here is my usual list of highlights on the updates and developments regarding medical device regulations in Russia and the Eurasian region over the last month:

1.Russia Updated Assessment Requirements for Software as Medical Device

On 26 May, 2021, the Russian Ministry of Health published the Oder #386N (link in Russian) and updated the algorithm of registration expertise for software as a medical device (SaMD) previously proposed in July 2020.

Among other updates, the published regulation proposed a one-step assessment process (similar to the current assessment pathway for low class devices and IVDs) and also emphasised mandatory requirements for providing for the assessment of the photos of the user interface and carrier of the SaMD.

It should be recalled that the national rules for registration of the SaMD, as well as requirements for the technical file and instruction for use, were updated in a similar way at the end of 2020.

2. Requirement on Notification of Imported and Manufactured Medical Devices in Russia

On 14 May, 2021, the Russian Ministry of Health published a draft regulation (link in Russian) suggesting mandatory requirements for notification on every unit of any medical device imported in Russia or manufactured within the country for the purpose of safety monitoring by the regulator. According to the document, information on the name of the medical device and its modification, its serial number, its manufacturing and expiration date and the number and date of registration should be submitted using the Roszdravnadzor electronic system (Russian medical device regulator) within five days after importation or manufacturing release.

Another draft regulation published over the last month suggested a similar notification requirement for a medical device not requiring registration (link in Russian) and proposed mandatory notification for medical devices imported without registration for humanitarian, research or exhibition purposes; the same informational system would be used.

In this context, it should be also recalled that the requirement for mandatory notification on imported medical devices and in-vitro diagnostics intended for emergency usage in the prevention and treatment of coronavirus infection and approved in Russia according to accelerated procedure has been in effect in Russia since April 2020.

3. Uzbekistan will Recognise International Medical Device Approvals

There is interesting news from Uzbekistan. On 5 May, 2021, the government of the country released the order # УП-№6221 (link in Russian) and introduced the procedure of recognition of approvals for medical devices made by major international regulatory agencies.

According to the released document, since 1 June, 2021, all medical devices approved by the US FDA, European notification bodies, MHRA (UK), PMDA (Japan) or MFDS (Korea) will undergo a fifteen-day acceptance process without laboratory testing in the country.