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G MEDICAL CHINA IS GRANTED “GREEN CHANNEL” BY CFDA
• G Medical is the first company to gain green channel expedite approval path in 2018
• Approval will grant the company with local enterprise income tax reduction from the 25% to 15%
• The Company has passed technical inspection of the CFDA, setting the ground towards complete regulatory approval and production infrastructure setup
Mobile and e-Health company G Medical Innovations Holdings Ltd (ASX: GMV) is pleased to announce that its China-based subsidiary has been granted acceptance to the Green Channel expedited Guangdong Provincial CFDA (China Food and Drug Administration) regulatory approval process for Prizma medical smartphone case.
The subsidiary, Guangzhou Yimei Innovative Medical S&T Co. Ltd, is the first company to receive such approval by the Guangdong Provincial CFDA in 2018 (only 21 medical devices were approved by them in 2016), highlighting the prestigious nature of such recognition. This will allow the Company to move forward quickly towards final regulatory CFDA approval and commercialisation of the Prizma Medical Smartphone Case in China.
The special review and approval procedures put in place for innovative medical devices by the CFDA ensures and verifies the safety and effectiveness of products for the vast Chinese market, and represents a significant milestone for G Medical and its planned rollout in such an important market.
The Prizma is one of two key products developed by G Medical. It is aimed at everyday consumers focused on their health and wellbeing, and allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs. In addition, users can store their medical data in the cloud and share it with any third party including professionals and family.
In addition to such approval ensuring the Prizma can be successfully launched into China, it also delivers G Medical additional important benefits, including expedited future CFDA applications and a reduction in local enterprise income tax from the normal 25% down to 15%.
G Medical CEO Dr. Yacov Geva, said: “Guangdong CFDA Green Channel approval represents a strong vote of confidence that will allow the Company to expedite its regulatory obligations moving towards commercialisation stage. With FDA, CE and TGA approvals already granted for the Prizma Medical Smartphone.