Medical Devices Regulations

68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including

• (a) a statement of the expanded use;

• (b) a statement of the known and potential benefits and risks; and

• (c) any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively.