Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 11/20)
Character Range: 550965–560141

to the authorised person any documents relating to the device that the authorised person requires and allow the authorised person to copy the documents.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The manufacturer of the device must, on request from the Secretary, give the Secretary a copy of the health professional's request for the device within the period requested by the Secretary (which must be at least 10 working days starting on the day on which the Secretary's request is made).
2.13   Custom‑made medical device that is manufactured outside Australia                                                                                                                                                                                                                                                                                                                            (a) The sponsor must have procedures in place to ensure that the manufacturer of the device, at all times, has available:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) information relating to the design and manufacture of the device and to any changes to the device.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) The sponsor must have procedures in place to ensure that the manufacturer of the device allows an authorised person to do any of the following:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) enter, at any reasonable time, any premises at which the manufacturer or any other person deals with the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) inspect those premises;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) if the device is on those premises—inspect the device and examine, take measurements of, conduct tests on or require tests to be conducted on the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iv) inspect any thing on those premises that relates to the device and examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of any such thing;
                                                                                                                                                                                                                                                                                                                                                                                                    (v) make any still or moving image or any recording of those premises or any thing on those premises.
                                                                                                                                                                                                                                                                                                                                                                                                    (c) The sponsor must have procedures in place to ensure that the manufacturer of the device, if the manufacturer is asked to do so by an authorised person, produces to the authorised person any documents relating to the device that the authorised person requires and allows the authorised person to copy the documents.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The sponsor must, on request from the Secretary, give the Secretary a copy of the health professional's request for the device within the period requested by the Secretary (which must be at least 10 working days starting on the day on which the Secretary's request is made).
2.14   Patient‑matched medical device                                                                                                                                                                                                                                                                                                                                                               The sponsor must, before 1 November 2024, notify the Secretary in writing of each kind of patient‑matched medical device that is intended to be supplied in Australia on or after 1 July 2029 and of the following:
                                                                                                                                                                                                                                                                                                                                                                                                    (a) the name and address of the sponsor;
                                                                                                                                                                                                                                                                                                                                                                                                    (b) the name and address of the manufacturer of that kind of medical device;
                                                                                                                                                                                                                                                                                                                                                                                                    (c) the device nomenclature system code of that kind of medical device;
                                                                                                                                                                                                                                                                                                                                                                                                    (d) the medical device classification