Document ID: chunk:federal_register_of_legislation:F2023L01291:clause:1_1
Version: federal_register_of_legislation:F2023L01291
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 5755–6824

1         information about an adverse event or defect in relation to a medical device or other therapeutic good, that has been reported to the TGA and is recorded in the DAEN – Medical Devices (medical device adverse event report), as follows:
             (a) details of the medical device or other therapeutic good;
             (b) details of the manufacturer of the medical device or other therapeutic good;
             (c) details of the sponsor of the medical device or other therapeutic good;
             (d) details of any other therapeutic good reported to have been involved in the adverse event;
             (e) the description of the adverse event;
             (f) the event outcome;
             (g) the event type;
             (h) the report source category;
             (i) the date that the medical device adverse event report was received by the TGA;
             (j) the unique number allocated to the medical device adverse event report by the TGA

Part 2—DAEN – Medicines

Column 1  Column 2
Item      Kinds of therapeutic goods information