Six products have already been completely registered according to the facilitated scheme of registration of medical devices that can be deficient within the period from May to September. According to the current tendencies, the Government has made a decision to prolong the validity of the procedure for another one and a half year, i.e. till the 1st of January, 2025.
The validity period of the dossiers that have already been issued will also be prolonged. This is the task the Federal Service for Surveillance in Healthcare does in an automatic mode according to Resolution No.1643 dated the 19th of September, 2022. Since April, 2022, according to the mentioned scheme, the manufacturers and the vendors could receive an unlimited dossier with a smaller amount of the documents to be submitted and within a shorter time period, as well as make changes in the devices that had already been registered as regards the materials and the components.
Medical devices with low class of potential risk of their use, except for the sterile ones, could be registered by a notification when the required documents were submitted within 150 days and the device itself is delivered to an authorized body for trials within 5 days.
The main criterion for facilitated registration is that the medical device is included into the list of the deficient medical devices. This list is developed and published by the multi-agency commission that includes the representatives of several interested ministries and bodies. The rules of its work were established by the order of the Federal Service for Surveillance in Healthcare No.4282 in May.
The list of the medical devices that the Russian market can need includes the devices that have been considered as deficient according to the market analysis, the devices that are offered by vendors at price lower than average, and other devices all the commission members have decided to include into the list.
From May to September, the list has been enlarged for several times and now includes 1761 codes, namely, chemical agents and apparatuses for in vitro diagnostics, the devices used in regular medical practice, the life-supporting and stimulation devices, cancer markers, surgery equipment. The full list of names and designations is given on the web-site of the Federal Service for Surveillance in Healthcare.
The six devices have already been included into the register as a result of state registration according to the facilitated rules. Many devices are currently undergoing this procedure. Prolongation of the scheme use promises timely provision of the population and the medical organizations with high-quality medical devices and stimulates legal production of the required equipment in possibly great amount to face the case of foreign vendors leaving the Russian market.
