Medical Devices Regulations

68.01 The following definitions apply in this Part.

authorization

authorization means, unless the context requires otherwise, an authorization that is issued under section 68.12. (autorisation)

COVID-19

COVID-19 means the coronavirus disease 2019. (COVID-19)

COVID-19 medical device

COVID-19 medical device means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical contre la COVID-19)

List of Medical Devices for an Urgent Public Health Need

List of Medical Devices for an Urgent Public Health Need means the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)

List of Medical Devices for Expanded Use

List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)

UPHN medical device

UPHN medical device means any of the following medical devices for an urgent public health need related to COVID-19:

• (a) a medical device that is set out in Part 1 of the List of Medical Devices for an Urgent Public Health Need;

• (b) a medical device that belongs to a category of medical devices that is set out in Part 2 of the List of Medical Devices for an Urgent Public Health Need. (instrument médical BUSP)