What does r3.12 require?

Everything the manufacturer provides on the application of the conformity assessment procedures to a device, correspondence included, must be in English. Technical files maintained in another language therefore need certified English versions before they are given to the Secretary or a conformity assessment body.

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
r3.4-3.10 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
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