Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p16
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 16/20)
Character Range: 587358–593621

41MA or 41MAA of the Act; and                                                                                                                                                                                                        (c) The sponsor holds information or evidence to support:
       (c) the sponsor notice has not been withdrawn by the sponsor by a notice (the withdrawal notice) given to the Secretary, with the withdrawal taking effect:                                                                                                                                                                                                                                  (i) the statement made in the sponsor notice under subparagraph (b)(i) of the column headed "Kinds of medical devices" of this item; and
       (i) on the day specified in the withdrawal notice, being a day that is later than the day that notice is given to the Secretary; or                                                                                                                                                                                                                                                          (ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (b)(ii) of the column headed "Kinds of medical devices" of this item; and
       (ii) otherwise—on the day the withdrawal notice is given; and                                                                                                                                                                                                                                                                                                                                (iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;
       (d) the device is not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the device be stopped or should cease because:                                                                                                                                                                                                           including, in relation to a statement that the device complies with the essential principles, to demonstrate ongoing compliance with the essential principles.
       (i) the Secretary is satisfied that the supply compromises public health and safety; or                                                                                                                                                                                                                                                                                                      (d) The following statements are, and continue to be, correct:
       (ii) the Secretary is satisfied that the device does not comply with the essential principles; or                                                                                                                                                                                                                                                                                            (i) the statement made in the sponsor notice under subparagraph (b)(i) of the column headed "Kinds of medical devices" of this item;
       (iii) the sponsor has failed to comply with a request by the Secretary under paragraph (e) of the column headed "Conditions" of this item                                                                                                                                                                                                                                                    (ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (b)(ii) of the column headed "Kinds of medical devices" of this item;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;
                                                                                                                                                                                                                                                                                                                                                                                                     including, in relation to a statement that the device complies with the essential principles, that the device continues to comply with the essential principles.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) if requested by the Secretary, give the Secretary a notice, in a form approved in writing by the Secretary, stating either that the device complies with the essential principles or that the device is being imported or supplied (as the case may be) with the consent of the