Medical Devices Regulations
25 (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
(3) The Minister may lift the direction to stop the sale if
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