Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p34
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 34/43)
Character Range: 427351–430296

of device is used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, either:
 (a) the manufacturer must:
 (i) satisfy the requirements in the Australian Code of Good Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, published by the Therapeutic Goods Administration, as amended from time to time; and
 (ii) hold a manufacturing licence that is in force and authorises the carrying out of a step in the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods; or
 (b) the laboratory in which the kind of device is manufactured must:
 (i) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and
 (ii) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time.
 (3) If the kind of device is not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods, the laboratory in which the kind of device is manufactured must:
 (a) be accredited as a testing laboratory by NATA as meeting ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time; and
 (b) meet the National Pathology Accreditation Advisory Council standard Requirements for the Development and Use of in‑house In Vitro Diagnostic Devices (IVDs), as amended from time to time.

6B.4  Required technical documentation
 (1) The manufacturer of a Class 4 in‑house IVD medical device must have available technical documentation for that kind of device that:
 (a) is up‑to‑date; and
 (b) is in a form that, if requested by the Secretary, would allow an assessment to be carried out as to whether a device of that kind complies with the applicable provisions of the essential principles, the classification rules, and these conformity assessment procedures; and
 (c) contains the information mentioned in subclauses (2) and (3).
 (2) The technical documentation must contain information about the kind of device in relation to which the quality management system mentioned in subclause 6B.3(1) of this Part is to be applied, including the following:
 (a) details of the processes, systems and measures used for controlling, monitoring and verifying that the kind of device complies with the applicable provisions of the essential principles;
 (b) a general description of the kind of device;
 (c) details of the design specifications for the kind of device, including:
 (i) any medical device standard that has been applied