Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p31
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 31/43)
Character Range: 419585–422491

by the most recent of any previous notification given to the Secretary under subclause (1)—by the later of the following:
 (i) 1 July of the next financial year;
 (ii) 20 working days after manufacturing the device for the first time.

Accreditation requirements etc.
 (4) The laboratory in which the Class 1, 2 or 3 in‑house IVD medical device is manufactured must:
 (a) be accredited as a testing laboratory by NATA, or by a conformity assessment body determined by the Secretary, as meeting one of the following standards, as published by the International Organization for Standardization and as amended from time to time:
 (i) ISO 15189, Medical laboratories—Requirements for quality and competence;
 (ii) ISO/IEC 17025, General requirement for the competence of testing and calibration laboratories; 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.

6A.3  Information to be given to the Secretary
 (1) On request by an authorised person, the manufacturer of a Class 1, 2 or 3 in‑house IVD medical device must:
 (a) give to the Secretary, within the period specified in the request (which must not be less than 20 working days after the request is made), the following information in relation to the device and the quality management system applied to the device:
 (i) a copy of the documentation mentioned in subclause (2);
 (ii) data for the design of the device (for example, the results of any analysis of the device, calculations or tests);
 (iii) data for the manufacture of the device (for example, inspection reports, test data, calibration data, information about the qualifications of staff); and
 (b) arrange for tests specified by the authorised person to be carried out for the purpose of checking whether the quality management system is operating effectively.
 (2) The documentation must include the following information:
 (a) the manufacturer's quality objectives;
 (b) the organisation of the manufacturer's business, including a description of the following:
 (i) the organisational structure of the business;
 (ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
 (iii) the methods of monitoring whether the system is operating effectively, including whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
 (c) the design of the medical device to which the system is to be applied, including the following:
 (i) details of the processes, systems and measures used for controlling, monitoring and verifying that, at each stage of the design process, the device complies with the applicable provisions of the essential principles;