The facilitated procedure of state registration of deficient medical devices is picking up stream. According to the information given at the official web-page of the Federal Service for Surveillance in Healthcare, for the current moment, more than three thousands items have been registered.
The statement says that 2392 lots of all the medical devices applied for registration within the period since the Provision No.299 “On edition of the rules of registration of medical devices” has come into force (it has happened the 18th of March, 2020, as a result of epidemiological situation in the country and in the world and the consequent shortage of medicines and medical devices) have been successfully registered. Among the accepted devices, the most common are medical face masks, protective gloves, uniform for medical personnel of various categories.
Apart from accelerated mode of pendency of an application and formal inspection, such a facilitated registration differs from a common one in that it presumes a reduced scope of documentation that is required for issuing by the registration authority. However, the new rules are applicable only for the medical devices with low coefficient of possible hazard at use that are given in the corresponding list at the domestic level.
Nevertheless, under the conditions of deficiency, 717 parcels of medical devices that are used in emergency situations, to prevent emergency cases, to treat or to prevent diseases that can be potentially dangerous for the surrounding people or that are caused by harmful influence of radiation, biological or chemical factors, have been successfully registered according to the specified conditions within the mentioned time period. The majority of the registered items are reactive chemicals used to determine whether a patient is infected with coronavirus.
The Federal Service for Surveillance in Healthcare notes that it is the facilitated registration of needed medical devices that helped to provide the population timely with essential (amidst the pandemic) goods. For this reason, they reduced the period of state registration for several times. In Russia, it is from 5 up to 22 working days according to the item complexity.