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Schedule 3 Essential Principles
Technical Documentation & Essential Principles Evidence
Australian market access is supported by evidence demonstrating conformity with the Essential Principles. Technical documentation developed for the EU, US, UK or Canada can often be leveraged, but it must be assessed against the Australian classification, intended purpose, conformity evidence, labelling and application route.
When This Support Is Needed
Preparing for ARTG inclusion or a mandatory/discretionary TGA application audit
Using an EU MDR / IVDR dossier or FDA 510(k)/PMA submission as the starting technical package
Responding to a TGA post-market information request or compliance check
Introducing a high-risk, novel, implantable, software-based or combination technology in Australia
Updating an older technical file to reflect new Australian requirements such as UDI and cybersecurity
What We Challenge Before Submission
Gaps between marketed claims and underlying pre-clinical/clinical evidence
Essential Principles checklist citing standards without evidence traceability
Risk controls not verified in the test evidence or protocols
Different device configurations or test articles used across technical reports
Label / IFU claims broader than the clinical or performance substantiation
UDI information not controlled with the same discipline as core labelling data
Our Support Includes
Device description, intended purpose and variant specification mapping
Essential Principles (Schedule 3) applicability checklist and evidence mapping
Risk management and benefit-risk documentation (ISO 14971)
Design and manufacturing process verification information
Pre-clinical verification and validation evidence review
Biological evaluation / biocompatibility evidence (ISO 10993)
Sterilisation and microbiological validation documentation
Packaging, transport and real-time/accelerated shelf-life evidence
Electrical safety and EMC testing evidence (IEC 60601 series)
Software lifecycle documentation (IEC 62304)
Cybersecurity risk management and threat modelling evidence
Usability and human factors engineering files (IEC 62366-1)
Clinical evaluation report (CER) and clinical performance evidence
IVD analytical and clinical performance evidence mapping
Australian labelling, IFU, promotional claim and UDI consistency
Senior Regulatory Question:
Can each material claim on the Australian label be traced to risk controls and verification, validation, clinical or performance evidence in the dossier?
Harmonize Your Technical File for TGA Essential Principles
Our regulatory engineers map overseas technical dossiers to Schedule 3 Essential Principles and verify test report adequacy.