Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For paragraph 41HA(1)(b) of the Act, a kind of medical device mentioned in Part 1 of Schedule 4 is exempt from the operation of Division 3 of Part 4 - 11 of the Act.
(2) For paragraph 41HA(1)(b) and subsection 41HA(2) of the Act, a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 is exempt from the operation of Division 3 of Part 4 - 11 of the Act, subject to compliance with the conditions mentioned in column 3 of that item.
(3) If:
(a) a kind of medical device that is exempt from the operation of Division 3 of Part 4 - 11 of the Act ceases to be so exempt; and
(b) an application was made for the kind of device to be included in the Register before the device ceased to be exempt;
the kind of device is taken to be exempt from the operation of Division 3 of Part 4 - 11 of the Act until the application is determined.
Limited exemptions
(8) For a kind of medical device that is exempt under item 1.7 of the table in Part 1 of Schedule 4, the exemption, to the extent that it relates to a particular manufacturer of a patient - matched medical device, is subject to the condition that the exemption only has effect in relation to the first 5 patient - matched medical devices manufactured by the manufacturer in a financial year.