Document ID: chunk:federal_register_of_legislation:F2019L00426:clause:2_8
Version: federal_register_of_legislation:F2019L00426
Segment Type: clause
Provision Reference: sch 2 cl 8
Character Range: 25036–26849

8                                                                                                                                                             ISO 18362:2016 Manufacture of cell-based health care productsControl of microbial risks during processing                                                                                                                                                                                           for use in the validation and routine control of manufacturing processes used for cell-based health care products that are medical devices                                                                                                                                                                                                  (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               (b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations