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: 29905–31496

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 (whether or not it has a measuring function):
                                                                                       (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 has a measuring function (and 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)