The company completed a multi-stage independent audit process and expects to receive final certification documentation from the regulatory bodies within 3 weeks.
G Medical chief executive officer Yacov Geva said: “We are very pleased to have achieved CE, FDA and CFDA approval, which exemplifies the high-quality of our production facility and our strong in-country relationships.
“The company has been committed to achieving this major milestone in record timeframes and we now look forward to being able to meet the demand from our global partnerships and rapidly execute our commercial plans.”
The mobile and e-health company has numerous global agreements in place and the regulatory approvals enable production and distribution to territories requiring CE, FDA and CFDA certification to begin.
G Medical has a strong pipeline of customer demand and the increased production capacity will position the company to fulfil its expansion into the growing e-health market.
Preparations for the listing of Chinese subsidiary Guangzhou Yimei Innovative Medical Science and Technology Co Ltd on the Hong Kong Stock Exchange are ongoing.
The company has requested its securities remain in trading halt pending an announcement on a capital raising and a material acquisition.