Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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 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.