Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_1
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 1
Character Range: 91480–92235

1         Therapeutic Goods Administration  a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations

Division 2—System or procedure packs that are not Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, not Class 1 IVD medical devices, or not intended for export only

Column 1  Column 2                          Column 3                                                                                                 Column 4

Item      Regulatory authority              Declaration of conformity in relation to the system or procedure pack                                    Conformity assessment document in relation to each medical device