Because of COVID-19 pandemic, last March 30, 2020 the Canadian Minister of Health, Patty Hajdu, signed a provisional order allowing extraordinary regulatory exceptions to importation and selling of specific medical healthcare products in Canada (drugs, Medical Devices).
On Health Canada website an updated list of the Medical Devices currently authorized to the extraordinary rules is available.
Manufacturers and Importers must report to Health Canada the lack of specific Medical Devices needed for the COVID-19 emergency.
To add new types of Medical Devices to the list, an application module must be filled and sent electronically. The Department evaluates the application and gets in contact with the applicant for further explanations or specific information on the product.
When the medical device is listed, Importers must inform Health Canada filling in the COVID-19 Medical Device Exceptional Importation and Sale Notification Form available on the HC website at least five days before the importing date.
During the emergency period Canadian companies are exempted from applying the standard regulation requirements provided by Canadian MDR SOR/98-282 for Medical Devices, except for sections from 44 to 65.1 that remain effective.
All relevant forms and information are available on the Health Canada website.
Sources:
