Mr. Liang Lin reports
NUGEN MEDICAL DEVICES INC. PROVIDES UPDATE ON HEALTH CANADA LICENSE
Nugen Medical Devices Inc. is initiating a temporary halt on its devices in Canada due to the lapse of its licence with Health Canada.
The company's Health Canada licence became expired due to an untimely certificate renewal. This is not a suspension or cancellation related to regulatory compliance or enforcement action. The temporary status does not constitute a product safety risk. However, to remain compliant with Health Canada medical device regulations, Nugen is currently not selling the affected devices in Canada.
A new licence application has already been submitted, and Nugen has been in active communication with Health Canada throughout the process. Nugen is confident the licence will be renewed soon, and sales will resume once the new licence becomes available. The company's operations elsewhere in the world remain unaffected. The company will continue to provide updates when available.
About Nugen Medical Devices Inc.
Nugen develops next-generation needle-free devices for subcutaneous drug delivery. Its flagship InsuJet system is approved in 42 countries and is designed to improve the lives of millions of people with diabetes worldwide.
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