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COVID-19[Repealed, SOR/2023-277, s. 3]

COVID-19 medical device

COVID-19 medical device[Repealed, SOR/2023-277, s. 3]

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 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 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:

• (a) a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;

• (b) a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)