Medical Devices Regulations
37 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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