On 6 April 2020, the Russian government released the Resolution #430 (link in Russian) with a list of 108 medical devices and IVD products intended for emergency use for prevention and treatment of coronavirus infection (including lung ventilators, oxygenators, SARS immunological and molecular assays, sample extraction kits, artificial blood circulation machines, thermometers, facial masks, gloves and certain protective clothes).
-The Resolution #430 introduced simplified six days batch-by-batch approval process for medical devices and IVD products included in the list until the end of 2020; The new approval process will skip he current requirements for local testing according to 2n Regulation;
– Resolution #430 allows importation of non-registered medical devices and IVD products included in the list for the type testing and clinical trials without additional permits;
– Resolution #430 allows delivery/selling in Russia of non-registered single use medical devices included in the list upon condition of their disposal after 1 January 2021.
This is my monthly update regarding changes to medical device regulations in Russia and the Eurasian Union; this month will be entirely devoted to a review of recent legislation changes related to the coronavirus COVID-19 outbreak:
- On 26 March 2020, the Russian Ministry of Health announced a green channel regime for approval in Russia for medical devices intended for the diagnosis of coronavirus COVID-19 infection. The published letter on this matter (link in Russian) informs that ‘in condition on rules of submission of documents for registration are respected, medical devices intended for diagnosis of coronavirus infection will be performed in shortest time’. The same document also announced that pre-registration consultations with manufacturers regarding the approval of medical devices that are intended for the diagnosis of coronavirus COVID-19 infection are provided by expert institutions at no cost.
However, it should be noted that this announcement does not introduce any new approval track/route, but rather expedites the existing testing and registration procedure.The first coronavirus IVD assay was approved in Russia, according to the information from the national medical device register, on 11 February 2020.
For 30th March 2020, according to the Russian Minister of health, there are seven assays approved in Russia, and review of such applications <by the regulator> is performed “within one-two days”.
- On 18 March 2020, the Russian government released the Resolution #299 (link in Russian) and simplified the registration route for 36 types of low-class, protective medical devices, including surgical/protective face masks, respirators, medical protective clothes, surgical suits, medical gloves, overshoes, and others.
According to the published resolution, Roszdravnadzor, the Russian medical device regulator, will make a decision on the approval of such protective devices within five days from the receipt of the registration file; this will be carried out on the condition that a manufacturer provides documents confirming the safety and quality parameters of these devices (testing and trials reports) within five months from the approval from the regulator. In the case where discrepancies (between data submitted for registration and in the test reports) appear, such approval may be withdrawn. The above mentioned resolution was followed by methodical guidelines (link in Russian), clarifying a new, simplified procedure.
- On 2 March 2020, the Russian government released the resolution #233 (link in Russian) and implemented a temporary ban on the exportation of certain types of medical devices and protective equipment from Russia, including face/surgical masks, respirators, protective glasses, medical protective clothes, and others – 16 types of medical products are included in the restriction list. According to this resolution, the export ban on these devices will be effective until 1 June 2020.
- On 25 March 2020, the Eurasian Commission published the decision #25 (link in Russian) and annulled the importation customs fees for several medical devices intended for the diagnosis and prevention of COVID-19 infection, which are included in the special list provided in the same document – the list includes IVD assays, protective clothes, and personal protective medical products. The document grants exemption from fees on the importation of products on the list from 16 March until 30 September 2020, in the territory of the Eurasian Union.
- Since 26 March 2020, the Russian parliament has been discussing the draft federal law (link in Russian), which may grant the Russian government the right to introduce a special procedure for the approval of medical devices, as well as the suspension of the wholesale and retail sale of medical devices in Russia for up to 90 days in the case of an emergency or epidemic.
- All registration inspections for medical device manufacturers have been cancelled/postponed by the Ministry of Health of Belarus (link of the published letter in Russian), as well as the Kazak competent authority (link to the announcement in Russian).
The first cases of COVID-19 infection were reported in Russia on 31 January 2020, and until today the rate of infection continues to climb. On 30 March 2020, Russia closed its borders and imposed a nine-day national shutdown.