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Medical Devices Regulations

Version of section 25 from 2006-03-22 to 2016-07-16:

  •  (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that a Class I medical device may not meet the safety and effectiveness requirements, the Minister may request the manufacturer to submit, on or before a specified day, information to enable him or her to determine whether the device meets those requirements.

  • (2) The Minister may direct the manufacturer to stop the sale of a Class I medical device if

    • (a) the manufacturer does not comply with a request made pursuant to subsection (1) by the day specified in the request; or

    • (b) the Minister determines, on the basis of the information submitted pursuant to subsection (1), that the device does not meet the safety and effectiveness requirements.

  • (3) The Minister may lift the direction to stop the sale if

    • (a) the manufacturer provides the information requested;

    • (b) corrective action has been taken to ensure that the medical device satisfies the safety and effectiveness requirements; or

    • (c) the Minister’s determination was unfounded.

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