Australia Therapeutic Goods (Medical Devices) Regulations 2002 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

What does sch3-4 require?

Under Part 4 the manufacturer must run a quality management system for production and final inspection and arrange its assessment by the Secretary or an Australian conformity assessment body, with site and device information, system documentation, the undertakings to keep complying and to keep the system effective, the type examination evidence or clause 6.4 technical documentation, and the undertaking to pass on serious incident and recall information. The system must ensure devices conform to the approved type or technical documentation and include post-production review, corrective action and notification. Substantial changes to the system or covered devices must be notified and assessed; on request, documentation and data must be given and tests arranged; a declaration of conformity must be made (clause 4.7, not needed where the route uses the clause 6.6 declaration instead) and the records kept. This is the route that adds sterility assurance for sterile Class I and Class IIa devices.