Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p33
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 33/40)
Character Range: 120447–123154

Class 4 in‑house IVD medical device;
 (d) an IVD medical device that is intended for self‑testing;
 (e) an IVD medical device that is intended for point of care testing;
 (f) a spinal fusion implantable device.
Note: For the purposes of paragraph (f), examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures.
 (2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if:
 (a) the person intends to import, supply or export a medical device of that kind; and
 (b) either of the following is not included in the Register:
 (i) the product name of the device;
 (ii) information in relation to the manufacturer's intended purpose of the device.
 (3) The notice must:
 (a) specify the information mentioned in paragraph (2)(b) that is not included in the Register; and
 (b) be given to the Secretary no later than 20 business days before the intended import, supply or export of the device.

5.13  Conditions applying automatically—information about poisons (Act s 41FN)
 (1) This regulation applies in relation to a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard.
 (2) However, this regulation does not apply in relation to that kind of medical device if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of medical device.
 (3) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must not supply the device in Australia if the supply would contravene Part 2 of the current Poisons Standard.

Part 6—Suspension and cancellation from the Register

6.1  Period for revocation of suspension (Act s 41GD, s 63(2)(dd))
 (1) This regulation applies to an application to the Secretary under paragraph 41GD(2)(a) of the Act to revoke the suspension of a kind of medical device from the Register.
 (2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary.

Part 6A—Disposal of unused emergency medical devices

6A.1  Disposal of unused emergency medical devices
 (1) For subsection 41GY(2) of the Act, the 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: