Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_8
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 8
Character Range: 51170–52334

8              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                                                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
               and Medical Devices Agency