Medical Devices Regulations
35 (1) If the information and documents submitted in respect of an application for a medical device licence or a medical device licence amendment are insufficient to enable the Minister to determine whether a medical device meets the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before a specified day, additional information necessary for making the determination.
(2) In the course of examining the application, the Minister may require the applicant to provide samples of the medical device.
- SOR/2015-193, s. 7
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