Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada


Medical Devices Regulations

Version of section 10 from 2006-03-22 to 2022-09-26:

 A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to

  • (a) identify the risks inherent in the device;

  • (b) if the risks can be eliminated, eliminate them;

  • (c) if the risks cannot be eliminated,

    • (i) reduce the risks to the extent possible,

    • (ii) provide for protection appropriate to those risks, including the provision of alarms, and

    • (iii) provide, with the device, information relative to the risks that remain; and

  • (d) minimize the hazard from potential failures during the projected useful life of the device.

Date modified: