Medical Devices Regulations
Version of section 68.37 from 2024-01-03 to 2024-10-14:
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.
- SOR/2023-19, s. 7
- SOR/2023-277, s. 23
- Date modified: