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Medical Devices Regulations

Version of section 34 from 2016-07-17 to 2020-06-17:


 If the manufacturer proposes to make one or more of the following changes, the manufacturer shall submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change:

  • (a) in the case of a Class III or IV medical device, a significant change;

  • (b) a change that would affect the class of the device;

  • (c) a change in the name of the manufacturer;

  • (d) a change in the name of the device;

  • (e) a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

  • (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

  • SOR/2015-193, s. 5
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