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Medical Devices Regulations

Version of section 35 from 2006-03-22 to 2016-07-16:

  •  (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.

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