Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 12/30)
Character Range: 165969–168895

(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) a system that is designed to enhance the safe and effective use of implantable cardiac medical devices (an implantable cardiac medical devices registry).
 (2) An implantable breast medical devices registry, or an implantable cardiac medical devices registry, may involve any of the following:
 (a) collecting and analysing data and information in relation to the relevant medical devices;
 (b) monitoring the safety and performance of the relevant medical devices;
 (c) identifying particular medical devices (if any) in relation to which there are safety or performance risks or concerns;
 (d) providing information about the safety and performance of the relevant medical devices to:
 (i) authorities or bodies of the Commonwealth, a State or a Territory that have functions relating to therapeutic goods or health; or
 (ii) health professionals; or
 (iii) persons or bodies involved in the manufacture, importation or supply of the relevant medical devices in Australia; or
 (iv) patients; or
 (v) the general public.
 (3) For paragraph (2)(a), the following are examples of data and information that may be collected and analysed in relation to the relevant medical devices:
 (a) data and information relating to the safety and performance of the relevant medical devices;
 (b) data and information about any revision procedures relating to the relevant medical devices and the reasons for those procedures;
 (c) in relation to each particular medical device that has been implanted in a patient:
 (i) information identifying the medical device, including the brand and batch or serial number; and
 (ii) the date on which the medical device was implanted; and
 (iii) the name of the hospital or surgery where the medical device was implanted; and
 (iv) data or information that tracks the performance of the medical device and the patient outcomes following implant of the medical device.
 (4) The Secretary may enter into a written agreement with a person or body for the purpose of maintaining an implantable breast medical devices registry or an implantable cardiac medical devices registry.
 (5) An implantable breast medical devices registry or an implantable cardiac medical devices registry:
 (a) may be maintained at a place and in a form that is acceptable to the Secretary; and
 (b) may involve keeping records, or carrying out other actions, by electronic means.

10.5  Delegation—powers and functions under these Regulations
  The Secretary may, by signed instrument, delegate a power or function of the Secretary under these Regulations to an officer of the Department.

10.6  Delegation—powers under paragraph 41HB(1)(d) of the Act
 (1) In this regulation: