Medical Devices Regulations

68.13 No person shall import or sell a 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 I or II device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.