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 safety and effectiveness requirements, 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.