Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p30
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 30/40)
Character Range: 113277–115910

Register; and
 (b) the event or other occurrence may lead to the death of, or a serious injury to, a patient, a user of the device or another person; and
 (c) the existence of, probable rate of occurrence of, or degree of severity of harm caused by, the hazard was not previously known or anticipated by the manufacturer of the device; and
 (d) the manufacturer will be required to take prompt action to eliminate, or reduce the risk of, the hazard.
 (3) For paragraphs (1)(b) and (c), an event or other occurrence leads to a serious deterioration in the state of health of a person if the event or other occurrence causes, or contributes to:
 (a) a life‑threatening illness or injury suffered by the person; or
 (b) a permanent impairment of a bodily function of the person; or
 (c) permanent damage to a body structure of the person; or
 (d) a condition requiring medical or surgical intervention to prevent such permanent impairment or damage.

5.8  Conditions applying automatically—requirements in relation to information about kind of medical device (Act s 41FN)
  For subsection 41FN(4) of the Act, the information required for the purposes of paragraph 41FN(3)(e) of the Act in relation to a kind of medical device that is included in the Register in relation to a person is:
 (a) any information that the person is aware of relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
 (ii) any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the kind of device; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
  that has led to any complaint or problem in relation to the kind of device, no matter how minor; and
 (b) any information of the kind mentioned in subsection 41MP(2) of the Act that the person is aware of in relation to the kind of device.

5.8A  Conditions applying automatically—giving of report about adverse events or occurrences (Act s 41FN)
 (1) For the purposes of subsection 41FN(5A) of the Act, if the person in relation to whom a kind of medical device is included in the Register gives information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act to the Secretary within the period covered by paragraph 5.7(1)(a), (b) or (c) of these Regulations, the person must give a written report to the Secretary in accordance with this regulation.
 (2) The person must give the report to the Secretary before the end of the period of 120 days beginning on the day the person gave that information to the Secretary.
 (3) The