May the 27th, the Federal Service for Surveillance in Healthcare posted on the portal site of legal support the order that determines the main provisions of activities of the multiagency commission on establishing of the list of deficient medical devices. The devices included into this specified list can be registered within the jurisdiction of the Russian Federation according to the facilitated registration procedure. The market welcomed these news with enthusiasm. However, there are concerns that the list won’t cover all the items the market needs.
This order has been specially developed for implementation of the Peculiarities of trade of medical devices established by the Provision No.552 dated 04/01/2022 and contains, among other points, the conditions or facilitated or accelerated registration of such devices. The document also provides the rules of work of the special commission authorized to determine the deficient medical items required by the market and the population.
The composition of the commission will be represented by the following agencies: the Ministry of Healthcare, the Ministry of Economic Development, the Ministry of Finance, the Ministry of Industry and Trade and other organizations specified in the Provision No.552. Each of the mentioned legal bodies will receive a committee seat, but the Federal Service for Surveillance in Healthcare will be represented by two persons. The final composition will be proclaimed after the list of candidates is issued. The Service tends to establish it by the separate order.
Which issues will the commission consider? First of all, determination of deficient goods and estimation of risk of shortage according to the information provided by the State government bodies. Moreover, the itemized list will include the lots supplied at price that is lower than the average market costs.
The average cost of an item is calculated according to the price of public contracts registered in the unified buying system and awarded within a period from the 1st of March of the current year. If there is no such a contract within the given period, the cost is determined according to the average price of the last three contracts being valid for the period prior to the corresponding delivery offer.
The new document has been positively welcomed. However, the forecast can’t be stated as definitely optimistic till the certain list of medical devices is officially published. For example, Andrey Vilensky, the CEO of Meditex expressed the concern that many of the most wanted devices won’t be included into this list for some reasons. At the same time, he endorsed generally the idea of facilitation of the market access of deficient devices. All we need to is to wait for the certain items list and experience a new facilitated procedure of registration of the listed devices by the Federal Service for Surveillance in Healthcare.
Currently, the government has accepted the Peculiarities of trade of medical devices under the conditions of shortage that presume acceleration of registration to 22 working days as compared to the previous period of 50 working days. According to the information received in this April, the procedure of correction of registration portfolio should also be facilitated.
The mentioned changes are valid till the end of 2022. Then, the market situation, the political and economical background will make their further adjustments.
