Regulatory Clearance Canada

PainChek is pleased to announce it has received regulatory clearance from Health Canada, allowing it to move into the $5 billion in-home health and support services market in the country. 

Health Canada issued PainChek a license in accordance with its Medical Devices Regulations of the Food and Drugs Act for the Manufacture of Class I Devices for Distribution. 

The regulatory clearance follows the Company’s recent announcement extending its relationship with Montreal-based home health care software provider AlayaCare (ASX Announcement 28 October 2020). The two companies are already working together in Australia. 

With the regulatory clearance received, AlayaCare will provide lead generation and marketing support to PainChek in the Canadian market, with PainChek overseeing direct sales, implementation, training and technical support to customer’s in the region. AlayaCare will receive fees from PainChek for integration of the PainChek technology into their home care software platform in line with the Australian market agreement. 

Active selling to clients in the Canadian market wis expected to commence in the next quarter. 

 PainChek® CEO Philip Daffas said: 

“We are really pleased to have secured this approval from Health Canada, as it allows us to grow into the sizeable Canadian market with the help of our partner AlayaCare, but also move into aged care services and hospitals in Canada.”