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Medical Devices Regulations

Version of section 68.37 from 2024-01-03 to 2024-10-14:


 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

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