Australia Therapeutic Goods (Medical Devices) Regulations 2002 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

What does sch3-1.5-1.6 require?

Once its system has been assessed, a manufacturer that intends a substantial change to the system or to the devices within its scope must give written notice to whichever of the TGA or the Australian conformity assessment body assessed it and have the change assessed against clause 1.4, with the consequential documentation changes ready; after any change the system must still meet clause 1.4. For Class III, Class 4 IVD and Class 4 in-house IVD devices the manufacturer must also arrange examination of the device design by the Secretary or an Australian conformity assessment body, supplying the design, production process, intended performance and the clause 1.4(5)(c) design documentation, and any later substantial change to the design or intended performance must be reported and examined before it is relied on. Class IIb, IIa and Class 2 and 3 IVD devices under full QA are spared the design examination.