Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 11/30)
Character Range: 163349–166220

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 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.

10.3A  Custom‑made medical devices—information about supplies
 (1) A person commits an offence if:
 (a) the person is the manufacturer of a custom‑made medical device that is manufactured in Australia in a financial year (the relevant financial year); and
 (b) the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom‑made medical devices the person manufactured in the relevant financial year and that complies with subregulation (3).
Penalty: 10 penalty units.
 (2) A person commits an offence if:
 (a) the person is the sponsor of a custom‑made medical device that the person imported into Australia in a financial year (the relevant financial year); and
 (b) the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom‑made medical devices the person imported in the relevant financial year and that complies with subregulation (3).
Penalty: 10 penalty units.
 (3) A report under this regulation must:
 (a) be made in accordance with a form approved, in writing, by the Secretary; and
 (b) contain the information that the form requires.
 (4) Without limiting subregulation (3), the form may require details in relation to supplies of custom‑made medical devices covered by paragraph (1)(b) or (2)(b).
 (5) The Secretary must make the form available on the Therapeutic Goods Administration's website.

10.4  Offences—period for notifying adverse events (Act s 41MP)
  For paragraph 41MP(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MP(2) of the Act is the relevant period specified in regulation 5.7.

10.4AA  Civil penalty—period for notifying adverse events
  For the purposes of paragraph 41MPA(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MPA(2) of the Act is the relevant period specified in regulation 5.7.

10.4A  Secretary may maintain a system to enhance safe and effective use of particular medical devices
 (1) The Secretary may, for the purpose of performing his or her functions, or exercising his or her powers, in relation to therapeutic goods (including under the Act or under another law), maintain either or both of the following:
 (a) a system that is designed to enhance the safe and effective use of implantable breast medical devices (an implantable breast medical devices registry);
 (b)