Echo Therapeutics, Inc., a medical device company committed to advancing non-invasive continuous glucose monitoring (CGM) and similar technologies, recently announced that, after several requests from its strategic partner the Chinese government, Medical Technologies Innovation Asia (MTIA) believes that Echo’s locally produced needle-free CGM products will be declared a class 2 medical device. All the class 2 medical devices include a review period of 90 working days after the submission is filled with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA). A definitive and formal designation from the CFDA is determined only at the moment of submission.
As previously announced, Echo and MTIA are now concluding the process of manufacturing assets in China and are finishing internal testing to support the CFDA clinical trial and commercialization process. In addition, clinical sites for the 120-patient trial were identified and have been secured. After the CFDA approval, Echo and MTIA will be sharing net sales of Echo’s CGM in licensed territories.
Scott W. Hollander, who is Echo’s CEO an President said: “China represents the first key market for Echo and we are focused on supporting MTIA’s efforts to bring the technology to the 100 million diabetics in China. Additionally, we will build on this momentum as we move toward making our products accessible globally. In early June, I personally visited each of the manufacturing facilities in China and feel confident that MTIA has the assets in place to support their commercial efforts in the future.”
“While the formal and final designation is never made until submission, my team and I continue to build a strong relationship with the CFDA while we work diligently to bring this important product to the market,” added Bai Ge, Managing Director of MTIA.
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