Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 10/30)
Character Range: 160852–163605

regulation and before the end of 31 December 2022; and
 (b) that application is for inclusion in the Register of a kind of medical device covered by item 3A, 3B, 3C, 3D or 3E of the table in Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020, as that instrument is in force from time to time; and
 (c) the person making that application had made a request before the commencement of this regulation under paragraph 41GL(d) of the Act for cancellation of the entry of the kind of device that is the subject of that application.

Part 10—Miscellaneous

10.1  Authorised persons
  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:
 (a) an officer of the Department, of another Department or of an authority of the Commonwealth;
 (b) an officer of:
 (i) a Department of State of a State; or
 (ii) a Department or administrative unit of the Public Service of a Territory; or
 (iii) an authority of a State or of a Territory;
  being a Department, unit or authority that has functions relating to health matters.

10.2  Information about sponsor
 (1) The sponsor of a medical device must ensure that the sponsor's name and address are:
 (a) provided with the device in such a way that a user of the device can readily identify the sponsor; and
 (b) located in accordance with clause 13.2 in Schedule 1.
Penalty: 10 penalty units.
 (2) If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.
Penalty: 10 penalty units.

10.3  Custom‑made medical devices—information about manufacturer
 (1) The manufacturer of a custom‑made medical device that is manufactured in Australia must, within 2 months after the medical device is first manufactured in Australia, give the following information about the device to the Secretary:
 (a) the manufacturer's name and business address;
 (b) a description of the kinds of medical devices being custom‑made by the manufacturer (including the device nomenclature system code for any such devices).
Penalty: 10 penalty units.
 (2) The sponsor of a custom‑made medical device that is imported into Australia must, within 2 months after the medical device is first imported into Australia, give the following information about the device to the Secretary:
 (a) the sponsor's name and address;
 (b) the manufacturer's name and business address;
 (c) a description of