Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p34
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 34/40)
Character Range: 122914–125405

arrangements for disposal of unused emergency medical devices are set out in Schedule 3A.
 (2) Nothing in this regulation or in Schedule 3A is taken to prevent a disposal of unused emergency medical devices if:
 (a) the devices have become:
 (i) devices of a kind included in the Register under Part 4‑5 of the Act; or
 (ii) exempt devices under section 41HA of the Act; or
 (iii) devices that are the subject of an approval under section 41HB of the Act; or
 (iv) devices that are the subject of an authority under section 41HC of the Act; and
 (b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the devices.

Part 7—Exempting medical devices from inclusion in the Register

Division 7.1—Exempt devices

7.1  Exempt devices—general (Act s 41HA)
 (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.

7.2  Exempt devices—use in life‑threatening cases (Act s 41HA)
 (1) For paragraph 41HA(1)(b) of the Act, and without limiting regulation 7.1, a kind of medical device is exempt from the operation of Division 3 of Part 4‑11 of the Act if:
 (a) the kind of device is to be used in or on a person who is a Category A patient; and
 (b) the following conditions are satisfied in relation to the use of the device:
 (i) the person in