Medical Devices Regulations

68.24 The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall, annually before November 1 and in a form established by the Minister, provide the Minister with a statement signed by the holder or a person authorized to sign on the holder’s behalf

• (a) confirming that all the information and documents submitted by the holder with respect to the device are still correct; or

• (b) describing any change to the information and documents submitted by the holder with respect to the device, other than those to be submitted under section 68.14 or 68.34.