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Medical Devices Regulations

Version of section 37 from 2006-03-22 to 2016-07-16:


 No person shall sell a medical device from a lot of licensed in vitro diagnostic devices in respect of which terms and conditions were set out in the licence pursuant to section 36, unless

  • (a) the results and protocol of any test performed on the device in accordance with those terms and conditions have been provided to the Minister; and

  • (b) the Minister determines, on the basis of the information received under paragraph (a), that the device continues to meet the safety and effectiveness requirements.

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