Uscom Granted Type II Medical Device Sales Certification in China
A Type II Medical Device Business Registration Certificate was granted to Uscom China allowing it to sale directly all type II medical devices with NMPA approvals into the Chinese market.
Uscom China, the wholly owned subsidiary of Uscom Limited, can now sell all type II medical devices including USCOM 1A, Uscom BP+ and SpiroSonic digital ultrasonic spirometers, directly into the Chinese market. While all current Uscom business in China is based on USCOM 1A sales, Uscom currently has USCOM 1A in a re-approval cycle, and the Uscom BP+ and the SpiroSonic series of devices in their initial Chinese NMPA regulatory process. This new certification provides a platform for the direct sale of these devices following the completion of these regulatory approvals.
Uscom China now has a registered Beijing office with a Business License, a Foreign Trade Registration Record, a VAT General Taxpayer Qualification Form, a Certificate of Customs Declaration and full capital and trading bank facilities. This means Uscom China can employ local staff, directly import type II medical devices, and now, with the approval of the Type II Medical Device Business Certificate, can sell Uscom and other type II medical devices such as ultrasound devices, MRI and X-Ray devices and respiratory anaesthetic and emergency medical devices with NMPA registration.
Previously Uscom has sold devices through importation and registered selling agents to master distributors to access the Chinese market. This new Type II business certification will allow Uscom to directly work with the master distributors to more efficiently and comprehensively access the Chinese market and proceed to a more direct and profitable national sales model.
Executive Chairman of Uscom, Associate Professor Rob Phillips said, “We are not just selling products into China, we are building a long-term business in China based on a new business model. Following this certification we can now import, support and sell medical devices independently as we bring our seven new products to the Chinese market. As our NMPA submissions progress, we are preparing by building the on-ground resources to expand operations in the China market. We are also focused on expanding our current distribution, to create a wide-reaching sales organisation that can cover the expansive geography of China. This new business model provides us with transparency of our distribution, sales and pricing in China, critical aspects of our growing China business. This new license also permits us to import non-Uscom type II medical devices with NMPA approvals and sell them through our expanding national distribution channels as agents for other manufacturers.”
Uscom develops and markets advanced non-invasive cardiovascular and pulmonary monitoring technologies to assist in the care of patients with cardiovascular and pulmonary diseases. These diseases are increasingly prevalent and posing significant health care and economic challenges for China’s 1.4B population.