Health Canada lists a backlog of more than 50 companies waiting for the green light to distribute their test kits across the country, some of which have been waiting for more than a month.
Other countries, such as the United Kingdom, have approved the sale of specific brands of test kits within a few days.
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“If we get approval, it’s fantastic. Otherwise, it’s a bit of a challenge from that point of view, “said Jeff Stevens, CEO of Datametrex AI, which has reached an agreement with a South Korean manufacturer to sell its tests in Canada and other countries around the world. world, especially the United States.
He said his company has been on the waiting list for about two weeks, even though its product is what Health Canada has already approved in the form of a nucleic acid detection kit.
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“This is the type of test kits that Health Canada has prioritized as their preferred test kit due to the nature of the 20 minute test,” he said, “which is essential because this will keep people away from the health care infrastructure.
Stevens adds that his business has not even been on the list since its last update in March.
He said there could be many more companies like his not on the list but waiting for approval.
“I know they haven’t updated their website since the end of March because so many things are happening, so 52 are posted but there could be 152 at the moment” , did he declare.
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In a statement to Global News, Health Canada would not specifically state why dozens of countries are involved in the approval process, but said it had put in place an interim order “to help ensure faster and faster approval.” more flexible import and sale of medical devices necessary for Canada’s response to COVID-19, including test kits.
“An interim order is one of the quickest mechanisms available to the Government of Canada to help make health products available to respond to public health emergencies on a larger scale,” the agency said.
The federal government also added that it has a program called the “Special Access to Medical Devices Program” which allows physicians to obtain COVID-19 diagnostic kits not yet approved in Canada.
Meanwhile, Stevens said he wanted approval from Health Canada, but also understood the process.
“They have to test themselves and they are comfortable bringing devices that Canadians can use and they will be safe and they will perform accurate tests.”
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