Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 9/20)
Character Range: 532191–542743

(i) whether the device complies with the essential principles;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) whether the conformity assessment procedures have been applied to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part 5‑1 of the Act or the Therapeutic Goods Regulations 1990.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) 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 changes to the device and quality management system.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) 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.
                                                                                                                                                                                                                                                                                                                                                                                                    (g) 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.
                                                                                                                                                                                                                                                                                                                                                                                                    (h) 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.
2.10A  Medical device that is a Class 4 in‑house IVD medical device and that is intended by its manufacturer to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person's body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product  (a) The device must comply with the essential principles.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.
                                                                                                                                                                                                                                                                                                                                                                                                    (c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) whether the device complies with the essential principles;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) whether the conformity assessment procedures have been applied to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part 5‑1 of the Act or the Therapeutic Goods Regulations 1990.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) 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 changes to the device and quality management system.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The manufacturer of the device must allow