The Conversation (0)
Miraculins Inc. (TSXV:MOM) announced that it has completed all required preparations for the submission of its Scout DS® device for product testing in compliance with Chinese Food and Drug Administration requirements. Miraculins has been working with Emergo Global, its lead Chinese regulatory consultant, on compiling and translating technical documentation required for submission to enable product testing to begin. Product testing is the first major step towards regulatory approval for the Scout DS® in China.
As quoted in the press release:
Preparation for CFDA product testing was significant and included the translation of Scout DS® device engineering drawings, circuitry diagrams, operating manuals, ISO documentation, as well as all of the internationally-recognized electrical, safety, mechanical and related testing and performance documentation that the Company already had on file for the Scout DS® related to its prior clearances in Canada and the European Union.
Miraculins has also been working with Emergo Global to evolve a comprehensive regulatory strategy in China overall, that additionally includes the development of a study protocol for the Scout DS® clinical trials that will be conducted in China following the successful conclusion of the product testing process.
“The Company has completed a significant amount of work related to the preparation and translation of all required materials for its formal product testing submission,” said Christopher Moreau, President and CEO of Miraculins. “While the regulatory process in China is involved and time consuming, we remain focused on the end goal which is to secure CFDA regulatory clearance and commence the sale and distribution of Scout DS® diabetes screening devices into Mainland China under the terms of our previously announced agreement.”
The agreement between Miraculins and a privately-owned, Hong Kong based medical device import company named Catalyn Technologies, established the framework for the sale and distribution of up to $90 Million USD in Scout DS® Diabetes Screening Devices in Mainland China, and also included the appointment of Cachet Pharmaceutical Co., Ltd. (“Cachet”) as the exclusive Scout DS® distributor in the territory. Cachet is a 15.8 Billion RMB market cap (or about $2.6 Billion USD) wholesale/retail drug distribution and medical device distributor. Cachet’s largest shareholder, the China Youth Industrial Development Corporation, is owned directly by the Central Committee of the Communist Youth League of China. Cachet is also listed on the Shenzhen Stock Exchange (stock name: Cachet; stock code: 002462).
Click here to read the Miraculins Inc. (TSXV:MOM) press release
Click here to see the Miraculins Inc. (TSXV:MOM) profile.