Medical Devices Regulations
34 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, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.
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