Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 5/20)
Character Range: 497242–507003

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 used at that site, 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.
                                                                                                                                                                                                                                                                                                                                                                                                    (ha) The notification must be accompanied by the notification fee specified in paragraph (b) of item 1.8 of Schedule 5.
                                                                                                                                                                                                                                                                                                                                                                                                    (i) The sponsor must comply with requests by an authorised person, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial).
                                                                                                                                                                                                                                                                                                                                                                                                    (j) If a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised person, whether made before or after the start of the trial, to give information about the conduct of the trial.
                                                                                                                                                                                                                                                                                                                                                                                                    (k) The sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised person to do the things mentioned in regulation 7.4.
                                                                                                                                                                                                                                                                                                                                                                                                    (l) The sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) if requested in writing by the Secretary, give the Secretary specified information or documents relating to the safety or performance of the medical device covered by the trial; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) do so within 14 days of receiving the request or such longer period (if any) allowed in writing by the Secretary.
2.4    Medical device that is imported into Australia by a member of a group of persons who are visiting Australia to participate in a national or international sporting event                                                                                                                                                                                                                     (a) The device must be for use in the treatment of a member or members of the visiting group.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) The importation of the device must not be prohibited under the Customs (Prohibited Imports) Regulations 1956.
                                                                                                                                                                                                                                                                                                                                                                                                    (c) The device must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The device must be destroyed or removed from Australia at the end of the visit.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) A member of the group must be responsible for the control and custody of the device while the group is in Australia.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) The person mentioned in paragraph (e) must:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) carry a list, in English, of the quantity and nature of the device imported; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) keep a record of the use of the device while the group is in Australia; and
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) produce the list