Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_6
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 6
Character Range: 42290–43249

6          Japan's Ministry                                                         either of the following:                                                                                                                                                            either of the following:
           of Health, Labour and Welfare or                                            1.      a MDSAP certificate; or                                                                                                                                                     1.      a pre-market certification issued under the Japanese PMD Act; or
           the Japanese Pharmaceuticals and Medical Devices Agency                     2.     a quality management system certificate for the purposes of the Japanese PMD Act                                                                                             2.     a pre-market approval issued under the Japanese PMD Act