G Medical finally has approval to start making its medical devices in China
Medtech G Medical has finally received the approvals it needs from three regulatory bodies to begin making its medical devices in China, months after it initially hoped.
G Medical (ASX:GMV) makes digital products that help monitor a person’s health.
Its ‘Prizma’ Medical Smartphone Case turns a smartphone into a clinical grade mobile medical monitor to measure vital signs such as ECG, respiration, oxygen saturation, heart rate, temperature and stress analysis.
It has been waiting on approval from authorities in the United States, China and Europe.
Back in March, G Medical told the ASX it was expecting approval before the end of the 2018 financial year. It said that was the reason it had not yet sold any of its Prizma devices since telling investors a year ago that it had signed a distribution deal worth up to $110 million.
Now the approval has finally come through. G Medical today told investors it expects to receive “final certification documents” within three weeks.
“The company has numerous agreements in place globally and the approvals granted for the Guangzhou Facility enables the Company to commence production and distribution to those territories which recognise CE, FDA and CFDA certification and have already granted regulatory approval for the company’s medical devices,” it said in a statement.
“G Medical has a strong pipeline of customer demand and the increased production capacity positions the Company to fulfil its expansion into the rapidly growing E-Health market.”
The company is currently in trading halt, and requested it remain in place until an announcement regarding a capital raise and an acquisition, expected tomorrow.