Australia Therapeutic Goods (Medical Devices) Regulations 2002 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

What does sch3-2 require?

Under Part 2 the manufacturer must arrange for the Secretary or an Australian conformity assessment body to examine the type, having ready its name and address and documentation on the type's design, manufacture and intended performance: a general description and variants, design drawings and explanations, manufacturing methods, the sterilisation method if supplied sterile, standards applied wholly or partly and solutions used where they were not, design calculations, risk analyses and test results, the clause 7.4 and tissue-origin statements, the clinical evidence and the information to be supplied. It must provide a sample, further samples on request, and access to any device the type connects to. A planned substantial change to the design or intended performance must be notified in writing and examined. The type documentation, change records and TGA or body documents must be kept for at least 5 years after the last device of the type and made available on request.