Completes Health Canada Review To Sell Covid-19 kit Sales of Kai Care Kits Under Original MDEL Licence Approved
VANCOUVER, BC / ACCESSWIRE / December 1, 2021 / EMPOWER CLINICS INC. (CSE:CBDT)(Frankfurt:8EC)(OTCQB:EPWCF) ("Empower" or the "Company") an integrated healthcare company - serving patients through medical centers, telemedicine platforms, a medical device company, and a high complexity medical diagnostics laboratory - is pleased to announce that it is has received approval from Health Canada to proceed under the original Device Class I authorization for Kai Care COVID-19 At-Home Saliva Collection Kit ("Kai Care Kits").
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. The Company temporarily paused the product's sale in September 2021 to participate in a review with Health Canada on the most appropriate medical device classification. The Company successfully responded to the request and is pleased to report it can continue operating under the original classification with updated labelling.
Ahead of resuming Canadian sales, the Company is preparing reactivation steps such as updating the product labelling, instructions and e-commerce site based on the revised framework from Health Canada. Kai Care products remain fully available in the U.S. market.
"Our team worked closely with Health Canada on the Kai Care Kit classification," said Steven McAuley, Chairman and CEO of Empower. "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."
This press release is available on the Empower Clinics Verified Forum on AGORACOM for shareholder discussion, questions and engagement with management https://agoracom.com/ir/EmpowerClinics
ABOUT EMPOWER:
Empower is an integrated healthcare company that provides body and mind wellness for patients through its clinics, with digital and telemedicine care, a medical device company and world-class medical diagnostics laboratories. Supported by an experienced leadership team, Empower is aggressively growing its clinical and digital presence across North America. Our Health & Wellness and Diagnostics & Technology business units are positioned to positively impact the integrated health of our patients, while simultaneously providing long term value for our shareholders.
https://www.accesswire.com/675468/Empower-Clinics-Successfully-Completes-Health-Canada-Review-To-Sell-Covid-19-At-Home-Saliva-Collection-Kit 