SafeCare has been in business providing certified drug testing kits to businesses in Canada and the United States. SafeCare Laboratories recognized an ability to modify these tests to perform a similar test for the COVID-19 virus.
We have an application into Health Canada for their approval. We have been working closely with them, so when they asked us to pause our sales channel during their evaluation phase, we agreed. We have been fast-tracked in the United States for approval, and our new FDA approval means we can provide these tests into any environment – hospitals, pharmacies, etc. We are awaiting similar approval in Canada from Health Canada, and we paused while we work with them to get that approval.
If we don’t get approval, obviously we will focus on providing tests to the American market and to other markets where this product has been approved. It is our intention to deliver tests to the markets where there is a backlog in demand, and it was our belief Canada was one of those markets. If Health Canada is concerned about our tests, they have not communicated that to us. We continue to work with them to finalize Canadian approval, but again – there is a global shortage of testing products for this virus. We have a solution engineered from our experience in developing drug testing.
Health Canada - March 27
Health Canada is aware of the situation and has directed the company to take down their website and stop selling the product. This product is not authorized for sale in Canada. Healthcare professionals should only use devices that are authorized under the Interim Order or have a medical device licence. The Department will continue to follow-up to confirm that the company has stopped selling and advertising the product and will consider further actions if needed.
Health Canada is working to increase the access to diagnostic tests in Canada through an expedited review pathway. The list of authorized COVID-19 devices (with authorization dates) is available here and all licensed medical devices are listed in the Medical Device Active Licence Listing.
Selling or advertising health products that make false or misleading claims to prevent, treat or cure COVID-19 is illegal in Canada. The Department takes this matter very seriously and is taking action to stop this activity. Health Canada has received reports about health products that make false or misleading claims related to COVID-19 and is taking action to address them. The Department continues to monitor websites for false and misleading claims and is working with online retailers to ensure that products making unauthorized claims are removed from their websites.
Canadians who have purchased unauthorized health products are advised to stop using them immediately, and to consult a healthcare professional if they have used any of these products and have health concerns.
Health Canada response #2 - March 31
The Department encourages anyone who has information regarding potential non-compliant sale or advertising of any health product claiming to treat, prevent or cure COVID-19, to report it using the online complaint form.
On March 18, the Minister of Health signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits. The Interim Order will allow Health Canada to provide quicker and more flexible approval of the importation and sale of medical devices that are necessary for Canada’s response to COVID-19, including test kits. The list of authorized COVID-19 devices (with authorization dates) is available here and all licensed medical devices are listed in the Medical Device Active Licence Listing.
Public health laboratories across Canada and around the world are using tests that detect the presence of the virus that causes COVID-19. These tests are being prioritized for review by Health Canada to increase the number of tests available in Canada to detect active infections of COVID-19.
Serological tests—like the take-home tests being evaluated in the United Kingdom—have limitations. These tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. These tests are also being accepted for review; however, the World Health Organization does not currently recommend serological tests for clinical diagnosis and Health Canada is following this advice. Research into serological testing is ongoing within Canada and worldwide. The Department is working with the National Microbiology Laboratory to validate testing and research, along with expert advice, so that we can have confidence in the test results.
RayBiotech - April 2
RayBiotech works very hard to abide by the laws of every country where we sell products. We appreciate you bringing to our attention your ability to put the detection tests into your shopping cart and proceed up to the checkout process. We make no claims that this product is approved in Canada and have warning language both on our website and in the product literature about its limitations. In addition, to the COVID-19 detection tests RayBiotech sells many research products. We are making every effort to limit the shipment of this product to legitimate customers. To date we have declined to make any shipment of the rapid detection kits to Canada. We will continue to be diligent in this matter. Please
stay safe in these chaotic times.
Letter posted by SBL Testing Technologies Inc. on March 28
It was reported yesterday that SBL Testing Technologies Inc. (“SBL”) was requested by Health
Canada to stop advertising and selling our COVID-19 IgM/IgG Antibody Rapid Test Kits as “this
product is not authorized for sale in Canada”.
SBL has been very clear in all communications with our distributing partners and customers that
our COVID-19 Rapid Test is in the process of Health Canada licensing. There has been no claim that
the test kit had already received a license for sale in Canada by Health Canada. We are monitoring
the Health Canada licensing process daily and anticipate our COVID-19 Rapid Test by Assure Tech.
(Hangzhou) Co. Ltd to be issued a Class III medical device license in the very near future.
The status of the Health Canada application can be found at: https://www.canada.ca/en/health-
SBL has also communicated that any sale of our COVID-19 Rapid Test Kits would only be finalized
and shipped to any distributing partner or customer in Canada upon Health Canada licensing. To
date, there have been no COVID-19 Rapid Test Kits shipped to any distributing partner or customer
in Canada. The COVID-19 Rapid Test Kit is currently licensed for use in the US by the FDA, certified
in Europe (CE), and is being sold and used worldwide.
SBL has further guaranteed to all of our distributing partners and customers that any deposits on
reservations for COVID-19 Rapid Test Kits will be fully refundable if a Health Canada license is not
issued. In the meantime, SBL will continue to take reservations for our COVID-19 Rapid Test Kits in
Canada, as the timeline to manufacture and receive test kits in Canada is significantly growing due
to high global demand.
SBL Testing Technologies continues to strive to provide the highest quality testing technologies for
workplace applications. We strongly believe in the manufacturers we partner with to provide
quality testing technologies and have tremendous confidence in the COVID-19 Rapid Test.
SBL has fully complied with Health Canada’s request to remove advertising of the COVID-19 Rapid
Test on our Canadian website. The information will remain available for our US and international
If you have any questions, please feel free to contact SBL at your earliest convenience.
Richard J Robillard