Empower Clinics Inc. (CSE:CBDT, OTCQB:EPWCF) said it has received Health Canada approval to proceed under the original authorization for its Kai Care COVID-19 At-Home Saliva Collection Kit (Kai Care Kit).
The Kai Care Kit was originally authorized for sale in Canada —under a Device Class I designation through its Medical Device Establishment Licence (MDEL) Licence Number 16005— but sales were temporarily paused in September 2021 as the company participated in a review with Health Canada on the most appropriate medical device classification, the integrated healthcare company noted.
“The company successfully responded to the request and is pleased to report it can continue operating under the original classification with updated labeling,” Empower added.
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"Our team worked closely with Health Canada on the Kai Care Kit classification," Steven McAuley, chairman and CEO of Empower said in a statement.
Ahead of resuming sales in Canada, Empower is preparing reactivation steps such as updating the product labeling, instructions and e-commerce site based on the revised framework from Health Canada.
"Through this process, it was determined that the original device classification filing was correct. We are updating labelling, packaging and marketing in preparation for our launch, online and with pharmacy and retail outlets," added McAuley.
Kai Care products remain fully available in the US market.