Uscom Ltd’s (ASX:UCM) Chinese subsidiary has been granted a Type II Medical Device Business Registration Certificate in China.
Uscom China 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.
Building a long-term business in China
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.
Uscom executive chairman 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.”