While a number of global companies have limited their activities in the Russian Federation, in April 2022, the Russian government released several regulations “intended to improve the stability of the market for socially important goods and mitigate a risk of inventory shortage for medical devices caused by the economic restrictive measures imposed against Russia”.
On 1 April 2022, the Russian government released the resolution #552 (link in Russian) and introduced the possibility of the “fast track” registration for medical devices included the special list. The list of devices (which is not yet available for the 13 of April) to be approved released and maintained by the special commission.
Main updates introduced for registration of medical devices of all classes included in the list:
- Simplified structure of the registration dossier, a technical dossier may be submitted on behalf of the Russian authorizes representative;
- Clinical trials/assessment procedure in Russia is not required in case when a medical device is approved in the country of origin;
- Shortening timelines for the review: the formal overall registration timeline for this procedure is 22 days including 15 days for dossier evaluation and 7 days for the decision on registration with potential 30 days “stop-watch period” to reply on possible deficiency letter;
- Registration approval is granted in this case until 1 September 2023 and may open the possibility for “standard” registration without any limitation in expiration date.
Highlights for registration of non-sterile class I medical devices included in the list:
- Registration review may be done within five days (formal timelines) based on the assessment of administrative documents;
- Other documents of the registration dossier including test reports to be submitted within 150 days after approval;
- Mandatory submission of the sample of the device for the testing within five days; and performing the testing within 50 days after approval.
In addition to the “fast track” medical device approval process, the following regulations have been released over the last month:
- Government resolution #311 (link in Russian) imposed ban for export of certain medical devices included in the special list from Russia;
- Government decree #506 (link in Russian) legalized a “parallel importing” in Russia for certain goods including medical devices without the permission of the trademark holder;
- Federal Law #64 – FZ (link in Russian) obliged manufacturers and importers of medical devices to notified the regulator prior to suspend or terminate their activity in Russia;
Russian healthcare regulator Roszdravnadzor announced a regular meetings with foreign medical devices manufacturers with a purpose to discuss “the ways of further cooperation” and cancelled until the end of the year scheduled and un-scheduled audits.