Medical Devices Regulations
68.13 No person shall import or sell a COVID-19 medical device for which the manufacturer holds an authorization if the device has been the subject of any of the following changes unless the manufacturer holds an amended authorization:
(a) in the case of a Class III or IV device, a significant change;
(b) a change that would result in a change of 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 device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.
- SOR/2023-19, s. 7
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