Medical Devices Regulations

68.36 (1) The Minister may add a licensed medical device, or a Class II, III or IV medical device for which the manufacturer holds an authorization, to column 2 of the List of Medical Devices for Expanded Use and an expanded use to column 3 only if the following conditions are met:

• (a) the Minister has reasonable grounds to believe that there is an urgent public health need for the expanded use of the device that is related to the corresponding medical condition that is set out in column 1;

• (b) the Minister has sufficient evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks associated with it, having regard to

  • (i) the uncertainties relating to those benefits and risks, and

  • (ii) the urgent public health need for the device; and

• (c) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the expanded use of the device.

(2) In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

• (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;

• (b) the device is set out in column 2 of that list; and

• (c) the expanded use of the device is set out in column 3 of that list.

(3) In the case of a Class II, III or IV medical device for which the manufacturer holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

• (a) the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;

• (b) the device is set out in column 2 of that list; and

• (c) the expanded use of the device is set out in column 3 of that list.