A manufacturer of a Class 4 in-house IVD (where it does not use full QA) must implement a quality management system across design, production, packaging, labelling and final inspection. If the device is used in manufacturing blood, blood components, plasma derivatives or human cell and tissue products, it must either meet the Australian Code of GMP for those products and hold a manufacturing licence, or be a NATA ISO 15189 accredited laboratory meeting the NPAAC in-house IVD requirements; otherwise the laboratory route applies. It must keep up-to-date technical documentation allowing assessment (controls, description, design specifications and standards, risk analysis, connection evidence, tissue statement, test results, clinical evidence, information supplied and manufacturing methods), run a post-marketing system with prompt notification, make a clause 6B.6 declaration stating identifiers, class, nomenclature code and the GMP licence number or NATA accreditation number, keep records for at least 5 years after it stops making the device and produce them within a reasonable period on request, and notify the Secretary within 20 working days of making any Class 4 in-house IVD used to screen stool donors for faecal microbiota transplant products.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.