Last Tuesday, the Interdepartmental Commission approved new amendments to Decree of the Government of the Russian Federation No. 552, according to which items of field medical furniture are included in the list of medical devices for facilitated registration. The commission includes: folding beds, bedside tables, folding tables for examination and therapeutic procedures, tables for instruments and machines for installing stretchers with patients.
For some previously included in the list of medical devices, the description has been corrected and the names have been clarified. So, “kit” of medical products are replaced by “sets”.
The regime of facilitated registration of medical devices was established last spring. Its main goal is to prevent the shortage of medical devices in the new economic conditions. The rules for obtaining a perpetual registration certificate have been approved and the procedure for replacing raw materials and components in registered medical equipment has been simplified. It is allowed (subject to certain conditions) to register non-sterile medical devices with a low potential risk class on a notification basis.
According to the Order of Roszdravnadzor No. 4282, products are included in the list for facilitated registration if there is a lack of supply on the market or the risk of its occurrence, or in the case of delivery at a price below the average market price. The list may include other medical devices determined by the interdepartmental commission.
During 2022 and 2023 The list of products for facilitated registration was constantly updated and today it contains 1900 items. An impressive part of the list was made up of products for in vitro diagnostics.
In 2022, more than sixty medical devices passed the facilitated registration (according to Roszdravnadzor). The registration regime will last until 01/01/2025.