Russian Regulatory Approval and Distribution for USCOM 1A
- Russian regulatory certification for USCOM 1A Cardiac Output Monitor
- Russia a significant and growing European market
- Uscom continues global expansion
USCOM 1A has received Russian Certification of Registration for sale into the Russian market. The regulatory process is usually 12-18 months but took approximately 3 years following delays with the COVID pandemic. Uscom has worked closely with our experienced Russian distributor, Wondermed, to successfully manage this protracted regulatory process.
Background:
Russia has a population of ~150m and the world’s 12th largest GDP at ~$1.3T USD, and a medical health spend of 3.5% (~$45B USD). The medical market in Russia is anticipated to grow as the population continues to age and community health care expectations increase. In Russia medical devices for diagnostic or therapeutic applications must be registered at the central department of the Federal Service on surveillance in Healthcare and Social Development (Roszdravnadzor) in Moscow. After a period of evaluation and testing, Roszdravnadzor issues the certificate of registration permitting sale of the product in Russia.
Operations:
Uscom’s appointed Russian distributor, Wondermed, previously known as VOK Medical, has excellent local connections in critical care and paediatrics, and is experienced in Russian medical capital sales. Wondermed is now responsible for the importation and distribution of the USCOM 1A throughout Russia. Submission for BP+ and SpiroSonic is also being planned.
Commentary:
Executive Chairman of Uscom, Professor Rob Phillips said “Uscom’s growth continues to be strong despite the pandemic, and our strategy for incremental growth is simply more products, more distributors and more revenue, and we are delivering on this plan. Russia is a significant addition to our global network of countries that Uscom is approved to export into. In the last 2 months we have received CE for SpiroSonic AIR in Europe and SE Asia, NMPA for BP+ in China, and now USCOM 1A approval in
Russia. Combined with impending US FDA approvals for SpiroSonic and BP+, our “product regions” will have more than doubled over 12 months. For investors, what was once an ambitious and complex global strategy is becoming increasingly simple as Uscom continues growing operations and revenues by increasing products, regions and distributors, and builds a prosperous multi-product global business.”
Uscom devices:
Uscom manufactures and markets the USCOM 1A haemodynamic monitor, the Uscom BP+, central blood pressure and vascular health monitor, the Uscom SpiroSonic digital ultrasonic spirometers, and the VENTITEST and VENTITEST-S ultrasonic ventilator calibrators for optimising respiratory device performance.