In the second half of 2024, the Russian Federal Service for Surveillance in Healthcare Roszdravnadzor began revoking medical registrations for all oxygen concentrators and generators, following a reclassification of such devices.
This change means that these systems are no longer regarded as medical devices, and therefore do not require registration for use in healthcare institutions.
Key dates in this transition include:
- 23 July 2024: Registrations revoked for Provita LLC, KONVINS CJSC, and Grasys JSC
- 28 January 2025: Revocation extended to AirSep Corporation
According to an official statement by the Russian Federal Research Institute for Medical Technology Evaluation (VNIIMT), which operates under the Russian healthcare regulator Roszdravnadzor, oxygen concentrators and generators are now classified as technological (non-medical) equipment. As a result, they are no longer permitted to be directly connected to central medical gas pipeline systems typically used in hospitals.
As a result, use of these systems in medical institutions no longer requires registration. This regulatory change removes a significant barrier to procurement and enables greater flexibility for manufacturers and end users alike.
The update levels the playing field and fosters a more competitive market, opening new opportunities for ONH Systems and our partners.
