CE, FDA & CFDA Approval Granted for Guangzhou China Production Facility
Announcement posted by G Medical Innovations 30 Oct 2018
• CE, FDA and CFDA approval granted for the Company’s Guangzhou China Production Facility
• Allows for major increase to the Company’s global production capacity
October 30, 2018 – Sydney, Australia – Mobile and e-Health company G Medical Innovations Holdings Ltd (“G Medical” or the “Company”) (ASX: GMV) is pleased to announce it has successfully completed the independent audit process to achieve CE, FDA and CFDA regulatory approval for the Company’s Production Facility in Guangzhou China.
The Company is proud to inform its shareholders that it achieved excellent results during the multistage independent audit process conducted during September and October for all three regulatory bodies (CE, FDA and CFDA). The full audit has now been completed, and the results of the audit are expected to be published and searchable to the public later this week via the following directory; https://www.sgsgroup.com.cn/en/certified-clients-and-products/certified-client-directory
The Company expects to receive its final certification documentation from the Regulatory bodies within 3 weeks. This is a significant milestone for the Company which intends to utilise the full production capacity of its Guangzhou facility.
As previously announced to the market, 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.
G Medical CEO Dr. 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.”
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. As the Company continues its preparations for the listing of its Chinese subsidiary, Guangzhou Yimei Innovative Medical Science and Technology Co. Ltd, on the main board of The Hong Kong Stock Exchange (HKSE), the granting of CE, FDA and CFDA approval was an important achievement in this process.
The Company requests that its securities stay in trading halt, pending an announcement in respect of a convertible note capital raising and a material acquisition. The Company requests the trading halt until the market opens on 31 October 2018 or until the announcement is made, whichever is the earlier.
The Company is proud to inform its shareholders that it achieved excellent results during the multistage independent audit process conducted during September and October for all three regulatory bodies (CE, FDA and CFDA). The full audit has now been completed, and the results of the audit are expected to be published and searchable to the public later this week via the following directory; https://www.sgsgroup.com.cn/en/certified-clients-and-products/certified-client-directory
The Company expects to receive its final certification documentation from the Regulatory bodies within 3 weeks. This is a significant milestone for the Company which intends to utilise the full production capacity of its Guangzhou facility.
As previously announced to the market, 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.
G Medical CEO Dr. 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.”
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. As the Company continues its preparations for the listing of its Chinese subsidiary, Guangzhou Yimei Innovative Medical Science and Technology Co. Ltd, on the main board of The Hong Kong Stock Exchange (HKSE), the granting of CE, FDA and CFDA approval was an important achievement in this process.
The Company requests that its securities stay in trading halt, pending an announcement in respect of a convertible note capital raising and a material acquisition. The Company requests the trading halt until the market opens on 31 October 2018 or until the announcement is made, whichever is the earlier.
Corporate Advisors
Otsana Capital 108
Outram Street
West Perth WA 6005
Telephone: +61 8 9486 7244
www.otsana.com
Investor Relations
Viriathus Australia
Level 8/525 Flinders Street
Melbourne VIC 3000
Telephone: +61 2 8667 5360
www.viriathus.com
Media Enquiries
Closer Communications
David Wolf
Tel: + 61 411 111 787
david@closer.com.au
Otsana Capital 108
Outram Street
West Perth WA 6005
Telephone: +61 8 9486 7244
www.otsana.com
Investor Relations
Viriathus Australia
Level 8/525 Flinders Street
Melbourne VIC 3000
Telephone: +61 2 8667 5360
www.viriathus.com
Media Enquiries
Closer Communications
David Wolf
Tel: + 61 411 111 787
david@closer.com.au
About G Medical Innovations
G Medical (ASX: GMV) was founded in August 2014, aiming to be at the forefront of the digital health revolution, developing the next generation of mobile health (mHealth) technologies. The Company leverages the experience and expertise of its Board to deliver best-in-class solutions to address this global opportunity.
The Company specialises in innovative next generation mobile and e-health solutions and services using its suite of devices and software solutions with a view to driving multiple and recurring revenue streams, across numerous verticals and territories.
For more information on G Medical, please visit www.gmedinnovations.com