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For more information whether your device requires application audit, please visit this link: Document Requirements • DOC -TGA • Essential Principles (EP) • Applicable Device information- Intended purpose & Indication • Risk Management Report (plan, analysis and report) • FMEA Report • Labelling & Instruction for Use • Post market surveillance plan • Vigilance System • Manufacturing Information and Design • Usability Engineering File • Clinical Evaluation Report (CER) • Biocompatibility Report (Cytotoxicity, Irritation, Sensitization) • Biological Evaluation Report • Sterilization validation (if applicable) • Cleaning validation • Safety and performance testing • Software development plan including software risk assessment (if device contains software) • Transport validation • Service Life Report • Stability testing EC / ISO Certificate (if applicable) Quality Management System Two key requirements of the conformity assessment procedures for medical devices are that a manufacturer must implement: a Quality Management System (QMS) for the design, production, packaging, labelling and final inspection of a device, and inspection and quality assurance techniques that are to be applied during the production of a device The Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019– external site specifies relevant medical device standards for quality management systems and medical devices intended to be supplied in a sterile state

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