Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_1
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 36382–37901

1          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) for a medical device that the manufacturer intends to be supplied in a sterile state:
                                                                                        (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or
                                                                                        (ii) Part 4 (production quality assurance procedures);
                                                                                       (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state:
                                                                                        (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;
                                                                                        (ii) Part 3 (verification procedures);
                                                                                        (iii)Part 4 (production quality assurance procedures); or
                                                                                        (iv)Part 5 (product quality assurance procedures)