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(2) In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if
(3) In the case of a Class II, III or IV medical device for which the manufacturer holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if
68.031 No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless
(b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been authorized in accordance with Canadian law.
(2) If a medical device group is authorized, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to be authorized.
68.07 If a test kit is authorized, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to be authorized.
68.06 If a system is authorized, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to be authorized.
