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: 92235–93260

1         Therapeutic Goods Administration  a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations   a conformity assessment document in relation to each medical device contained in the system or procedure pack

Part 2—System or procedure packs that are intended to be supplied in a sterile state and that are not Class 1 IVD medical devices, or not intended for export only

Column 1  Column 2                                                                 Column 3                                                                                                                                                                            Column 4

Item      Regulatory authority                                                     Conformity assessment document relating to manufacturer's quality management system                                                                                                 Conformity assessment document relating to product assessment