Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:2_10
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 2 cl 10
Character Range: 71226–73405

10             Japan's Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency  either of the following:                                                                                                                                                           for an IVD medical device for self‑testing or an IVD medical device for point of care testing—one or more of the following:
                                                                                                                            (a) a MDSAP certificate; or                                                                                                                                                        (a) a pre-market certification issued under the Japanese PMD Act;
                                                                                                                            (b) a quality management system certificate for the purposes of the Japanese PMD Act                                                                                               (b) a pre-market approval issued under the Japanese PMD Act

Part 2—Class 3 IVD medical devices

Column 1 Item  Column 2                                                                                                   Column 3                                                                                                                                                                                                                              Column 4
                                                                                                                          Conformity assessment document relating to manufacturer's quality management system
               Regulatory authority                                                                                                                                                                                                                                                                                                                             Conformity assessment document relating to product assessment