Health Canada Approves Sales of Empower Clinic’s Kai Care Kits Under Original MDEL Licence
Dec 1, 2021 By MarketDepth
Empower Clinics Inc. (CSE: CBDT) (OTCQB: EPWCF) today received approval from Health Canada to continue the sale of its Covid-19 saliva collection kit under its initial Device Class I designation.
Paused Sales
The company paused sale of the Kai Care COVID-19 At-Home Saliva Collection Kit (“Kai Care Kits”) in order to take part in a review with Health Canada to determine the most appropriate medical device classification. Following completion of the review, the Kits can now continue to be sold under the original classification with updated labelling.
“Our team worked closely with Health Canada on the Kai Care Kit classification. Through this process it was determined that the original device classification filing was correct.”
Steven McAuley, Chairman and CEO of Empower
Prior to the resumption of sales, the company has undertaken several steps to update the product’s labelling, instructions as well as the e-commerce site based on the revised framework from Health Canada.