Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p31
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 31/40)
Character Range: 115685–118302

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 report must:
 (a) deal with any updates to that information since that information was given; and
 (b) set out details of the action the person has taken, or the manufacturer of the kind of medical device has taken, to investigate the event or other occurrence concerned; and
 (c) set out details of the action the person has taken, or the manufacturer of the kind of medical device has taken, to alleviate the impact of the event or other occurrence concerned for patients or for users of the kind of medical device; and
 (d) set out details of similar events or occurrences that have occurred in the last 3 years, in relation to the kind of medical device, of which the person is aware.

5.9  Conditions applying automatically—storage and transport of medical devices (Act s 41FN)
  For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must ensure that, while the person has control over a device of that kind, the device is stored and transported in accordance with the manufacturer's instructions for use of the device and any other information provided with the device by the manufacturer.

5.10  Conditions applying automatically—record‑keeping (Act s 41FN)
 (1) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must:
 (a) create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and
 (b) create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution.
 (2) A record created under subregulation (1) must be kept:
 (a) for 10 years if the record relates to one of the following kinds of device:
 (ii) a Class III medical device;
 (iii) a Class IIb medical device that is an implantable medical device;
 (iv) a Class 4 IVD medical device; or
 (b) for 5 years if the record relates to any other kind of device.

5.11  Conditions applying automatically—reporting (Act s 41FN)
 (1) This regulation applies in relation to the following kinds of medical devices:
 (b) a Class III medical device;
 (c) a Class IIb medical device that is an implantable medical device;
 (d) a Class 4 IVD medical device.
 (2) For