Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p38
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 38/40)
Character Range: 132439–135267

conducts its activities within the geographic area where the medical practitioner is engaged in treating patients.
 (2) A class of recipients prescribed for the purposes of paragraph 41HC(4)(c) of the Act is the class of recipients each of whom is a person who is suffering from a life‑threatening or otherwise serious illness or condition.
 (3) For subsection 41HC(4) of the Act, each of the following is an exceptional circumstance in which paragraph 41HC(4)(b) of the Act does not apply:
 (a) the Secretary is satisfied that the medical practitioner has no access to an ethics committee;
 (b) the medical practitioner has an endorsement from a specialist college that does not have an ethics committee, but has expertise relevant to the treatment of the condition for which the authority is sought.

7.7  Circumstances for supply of device under authority (Act s 41HC)
  For subsection 41HC(5) of the Act, a kind of medical device may be supplied under an authority under subsection 41HC(1) of the Act if the supplier of the device complies with the directions relating to the therapeutic intervention, or class of therapeutic intervention, mentioned in the authority.

7.8  Information to be notified in relation to supply of certain medical devices
  For the purposes of paragraph 41HC(6C)(b) of the Act, the information that must be contained in a notification under subsection 41HC(6B) of the Act in relation to the supply by a health practitioner of a medical device to a person is as follows:
 (a) the person's initials, date of birth and gender;
 (b) each medical condition in relation to which the device was supplied;
 (c) each intended use of the device in relation to which the device was supplied;
 (d) the product name of the device;
 (e) the name of the manufacturer of the device;
 (f) a brief description of the device including whether the device is a variant;
 (g) the practitioner's name, AHPRA number and contact details;
 (h) the health profession in which the practitioner is registered or licensed to practise;
 (i) the address of the practitioner's principal place of practice.

Part 8—Obtaining information

8.1A  Matters for which information and documents can be requested
  For paragraph 41JA(1)(j) of the Act, the following matters are prescribed:
 (a) whether the devices are medical devices;
 (b) whether the devices are intended for a specified purpose, as ascertained under subsection 41BD(2) of the Act;
 (c) whether the devices are correctly classified under Division 3.1 of Part 3;
 (d) whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD(e) or (g) of the Act;
 (e) whether the devices contain substances that are prohibited imports under the Customs