Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 4/20)
Character Range: 488750–498250

before importing the device, have lodged an application under section 41FC of the Act for the device to be included in the Register.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) If the application is not successful, the device must be destroyed or returned to the consignor of the device within 1 month of the decision not to include the device in the Register.
2.3    Medical device to be used in a clinical trial solely for experimental purposes in humans                                                                                                                                                                                                                                                                                                     (a) The sponsor must notify the Secretary:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) in a form approved by the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;
                                                                                                                                                                                                                                                                                                                                                                                                     about the trial and the medical device covered by the trial and must do so before:
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) the medical device begins to be used in the trial, unless subparagraph (iv) applies; or
                                                                                                                                                                                                                                                                                                                                                                                                    (iv) if the sponsor seeks the Secretary's agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) The notification must be accompanied by the notification fee specified in paragraph (a) of item 1.8 of Schedule 5.
                                                                                                                                                                                                                                                                                                                                                                                                    (c) The approval of the device for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The terms of the approval by the sponsor, body or organisation mentioned in paragraph (c) must be no less restrictive than the terms advised by the responsible ethics committee.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The trial must not be the subject of a direction by the Secretary that the trial not be conducted, or that it be stopped, because the Secretary has become aware that to conduct or continue the trial would be contrary to the public interest.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) The sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the responsible ethics committee that is inconsistent with the continuation of the trial.
                                                                                                                                                                                                                                                                                                                                                                                                    (g) The conditions stated in regulation 7.5 must be complied with, as if that regulation applied to a person using a medical device under this item.
                                                                                                                                                                                                                                                                                                                                                                                                    (h) The sponsor must notify the Secretary:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) in a form approved by the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;
                                                                                                                                                                                                                                                                                                                                                                                                     about any trial site not covered by the notification referred to in paragraph (a) and must do so before:
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) the medical device begins to be