What does sch3-5 require?

Under Part 5 the manufacturer must run a product quality management system for final inspection and testing and arrange its assessment by the Secretary or an Australian conformity assessment body, with the same supporting information and undertakings as the other system routes. The system must make sure each device, or a representative sample of each batch, is examined and tested to confirm it matches the approved type or the clause 6.4 technical documentation, and must include post-production review, corrective action and notification of serious incident and recall information. Substantial changes must be notified and assessed, documentation and tests supplied on request, a declaration of conformity made (clause 5.7, unless the route uses the clause 6.6 declaration) and the records kept.

Australia Therapeutic Goods (Medical Devices)...

Other controls in Part 3 Division 3.2 and Schedule 3: conformity assessment procedures – Australia Therapeutic Goods (Medical Devices) Regulations 2002

r3.11-sch3-8 Apply the clinical evaluation procedures to every device (custom-made devices included): obtain clinical investigation data or a documented literature review, evaluate it through competent clinical experts and document the clinical evidence in writing
r3.12 Provide all records and correspondence on the application of the conformity assessment procedures in English
r3.4-3.10 Apply the conformity assessment procedures the Regulations set for the device's class (or a higher class's procedures if preferred), including the extra steps for sterile, measuring, in-house IVD and special purpose devices
sch3-1.3-1.4 Full quality assurance: implement a quality management system covering design, production, packaging, labelling and final inspection, have it assessed, document it fully and build in post-market review, corrective action and notification of serious incidents and recall reasons
sch3-1.5-1.6 Full quality assurance: notify and have assessed any substantial change to the system or to the devices it covers, and for Class III, Class 4 IVD and Class 4 in-house IVD devices arrange design examination before supply and for every later substantial design or performance change
sch3-1.7-1.9 Full quality assurance: on request give the Secretary system documentation, design and manufacturing data and arrange tests; make a signed declaration of conformity with the clause 1.8 content; keep the clause 1.9 records for at least 5 years after the last device
sch3-2 Type examination: arrange examination of a representative sample with complete design, manufacturing, standards, test, clinical and labelling documentation, supply samples on request, notify and have examined substantial design changes, and keep the records for 5 years
sch3-3 Verification: have each device or a statistical batch sample examined and tested against the approved type or the technical documentation, keep production uniform, operate post-market review and notification, declare conformity and keep records

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia Therapeutic Goods (Medical Devices) Regulations 2002 controls