Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_2
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 46074–47534

2              Therapeutic Goods Administration                                         a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:                                                     a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)
                                                                                           1.      for a medical device that the manufacturer intends to be supplied in a sterile state:
                                                                                             1.    Part 4 (production quality assurance procedures);
                                                                                           1.     for a medical device that the manufacturer intends to be supplied in a non-sterile state:
                                                                                             1.       Part 3 (verification procedures);
                                                                                             2.     Part 4 (production quality assurance procedures); or
                                                                                             3.   Part 5 (product quality assurance procedures)