Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:2_1
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 2 cl 1
Character Range: 65686–66752

1         Therapeutic Goods Administration  a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations

Part 1—Class 2 IVD medical devices

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