Health Canada Introduces New Reporting Requirements to Reduce Shortages
In an effort to prevent device shortages during the COVID-19 pandemic, Health Canada has introduced new reporting requirements for devicemakers.
The agency said it will continue to allow certain products to be sold in Canada that may not fully meet Canadian regulations, but reports of any anticipated supply shortages are now required for such products, and the reports must be submitted in English and French.
Medical devices governed by the agency’s “exceptional importation and sale interim order” may be imported or sold in the country provided the importer or manufacturer has a medical device establishment license. To import or sell such devices, companies must first submit a request to add a medical device to the authorized list. Once a product is on the list, companies must notify the agency at least five business days before they import a designated device.