Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p29
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 29/40)
Character Range: 110850–113488

a medical device if:
 (a) either:
 (i) the priority applicant specified in the determination has not made an application under section 41FC of the Act for that kind of medical device to be included in the Register; or
 (ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and
 (b) the Secretary is satisfied that the criteria specified in subregulation 5.4B(2) are no longer satisfied in relation to the medical device.
Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment.
 (2) The revocation must be by written notice given by the Secretary to the priority applicant.

Division 5.2—Conditions
Note: Regulation 5.5 is intentionally not used.

5.7  Conditions applying automatically—period for giving information about adverse events etc (Act s 41FN)
 (1) For paragraph 41FN(3)(d) of the Act, the period in which a person in relation to whom a kind of medical device is included in the Register must give information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act to the Secretary is:
 (a) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the person becomes aware of the event or occurrence; and
 (b) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—10 days after the person becomes aware of the event or occurrence; and
 (c) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—30 days after the person becomes aware of the event or occurrence; and
 (d) in any other case—60 days after the person becomes aware of the information.
Note: See also regulation 5.8A (which deals with the giving of a report after information is given within a period covered by paragraph (1)(a), (b) or (c) of this regulation).
 (2) For paragraph (1)(a), an event or other occurrence, in relation to a kind of medical device, represents a serious threat to public health if:
 (a) the event or other occurrence is a hazard arising from a systematic failure of the device that becomes known to the person in relation to whom the device is included in the 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