What does sch3-3 require?

Under Part 3 the TGA or an Australian conformity assessment body must examine and test every device, or a statistically representative sample from each batch, at the manufacturer's arrangement, to confirm it conforms to the approved type (where type examination was used) or to the clause 6.4 technical documentation (where the declaration route was used), and that it meets the essential principles, classification rules and procedures. It must have ready its details, manufacturing process documentation, the procedures and undertaking that ensure uniform production, an undertaking to pass on serious incident and recall information, and the type or technical documentation, and make the devices or samples available. Its manufacturing process must reliably produce conforming devices and include post-production review, corrective action and notification. A declaration of conformity and the related records follow the same pattern as the other procedures.

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
sch3-4 Production quality assurance: implement and have assessed a quality management system for production and final inspection that ensures devices match the approved type or technical documentation, notify substantial changes, 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