The Government of the Russian Federation introduced a simplified procedure for registering of medical goods in April 2022 (Government Decree No. 552) until September 1, 2023 with the option of getting perpetual Registration Certificate and simplified the procedure for replacing raw materials and components in registered medical goods. It became possible to register medical products of a low class of potential risk, with the exception of sterile ones, on a notification basis, with providing of medical goods by an applicant for trials within five working days and subsequent providing of documents by an applicant within 150 days to an institute subordinate to Federal Service for Surveillance in Healthcare (FSSH).
At the end of May 2022, FSSH approved Order No. 4282 on the rules for the work of the Special Interdepartmental Commission, which determines the list of medical products for accelerated registration. The list includes positions with a risk of lack in the Russian market or in connection with the application for the supply of medical devices at a price below the market average one, based on the prices of contracts concluded after March 1, 2022.
In June of the same year, the list included 37 kinds of reagents and laboratory equipment for in vitro diagnostics. Three weeks later, the list was expanded to more than 1.5 thousand items. About half of the list consisted of reagents for in vitro diagnostics, as well as laboratory equipment and specialized consumables. In addition to them, the list includes dental equipment (lamps, scanners, X-ray systems) and consumables, equipment for anesthesiology and resuscitation, including artificial lung ventilation devices, consumables for interventional surgery, including implantable (stents and catheters), cardiac monitors.
Gradually, the list expanded and by the beginning of 2023 it already consisted of more than 1.8 thousand items.
In March 2023, the Special Interdepartmental Commission added five more positions to the list, among them: ultrasonic inhalers, ankle joint simulators, examination/procedural nitrile, powder-free, non-antibacterial gloves, a kit for intravenous infusions and a kit for in vitro diagnostics of spinal muscular atrophy. A month later, the list was replenished again, this time with clumsy powered wheelchairs controlled by the patient or attendant.
According to FSSH, in 2022, 31 products were registered by simplified procedure. In September 2022, the simplified registration regime was extended until January 1, 2025.
Under a simplified procedure of registration, it is now allowed to register surgical forceps for manipulating soft tissues, a tool for introducing and compacting dental materials, a hook for removing dental plaque, an endodontic plugger, a dental probe, and a reservoir for an insulin infusion pump. Hand-held scalpel blades, a cytological ecclesiastical brush, Clostridium difficile antigen kits for in vitro diagnostics, and medical video recorders were also addes to the list. The list does now consist of 1930 items.
