Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p10
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 10/20)
Character Range: 541308–551598

times, have available:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) information relating to changes to the device and quality management system.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The manufacturer of the device must allow an authorised person to do any of the following:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) inspect the premises and the device, and examine, take measurements of, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) make any still or moving image or any recording of those premises or anything on those premises.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.
                                                                                                                                                                                                                                                                                                                                                                                                    (g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.
2.11   Unused emergency medical devices directed by the Secretary, under clause 7 of Schedule 3A, to be exported                                                                                                                                                                                                                                                                                    compliance with Schedule 3A, as if section 41GY of the Act applies to the devices
2.12   Custom‑made medical device that is manufactured in Australia                                                                                                                                                                                                                                                                                                                                 (a) The manufacturer of the device must, at all times, have 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 manufacturer of the device must allow an authorised person to do any of the following:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) enter, at any reasonable time, any premises (including premises outside Australia) 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) If asked to do so by an authorised person, the manufacturer of the device must produce 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