- Uscom (UCM) receives Chinese regulatory National Medical Products Administration (NMPA) acceptance for four devices in its range of SpiroSonic spirometers
- This acceptance comes after more than two years of national testing by the regulatory body, which regulates medical device approval in China
- The company will be required to pay a registration fee within 15 working days from the grant and will therefore be allowed to sell its spirometers into the Chinese market for five years once approval is received
- Shares in Uscom hold steady at 6.5 cents at market close
Uscom (UCM) has been granted Chinese regulatory National Medical Products Administration (NMPA) acceptance for four devices in its range of SpiroSonic spirometers through its wholly-owned subsidiary, Uscom China.
The NMPA is a regulatory body, which regulates medical device approval in China.
This acceptance comes after more than two years of national testing and three months after a manufacturing and research and development agreement with Foxconn was executed for the manufacture of Uscom devices in Beijing.
The company will be required to pay a registration fee within 15 working days from the grant.
The submission will allow for the sale of Uscom spirometers into the Chinese market for a period of five years once the approval is issued.
Executive Chairman Professor Rob Phillips said the NMPA acceptance is a significant commercial leap for Uscom into the most populous medical and medical consumer market in the world.
“Uscom looks forward to activating our expanding sales teams to convert this opportunity to revenue,” he said.
“The SpiroSonic world leading technology provides research grade monitoring in a digital environment with an easy to use and disinfect technology suited to clinical and eHealth environments.”
Shares in Uscom held steady at 6.5 cents at market close.