Australia Medical Device Audit Checklist (TGA)
This audit checklist covers TGA regulatory requirements for medical devices under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. Ensures compliance with Essential Principles, Australian Register of Therapeutic Goods (ARTG) requirements, and ISO 13485 quality management systems. Complete this audit annually or as required by your quality management system.
- Industry: Healthcare
- Frequency: Annually
- Estimated Time: 40-55 minutes
- Role: Quality Manager / Regulatory Affairs Officer
- Total Items: 28
- Compliance: Therapeutic Goods Act 1989, TG (Medical Devices) Regulations 2002, Essential Principles, ISO 13485, ARTG Requirements
ARTG Registration & Compliance
Verify ARTG listing and registration requirements.
- ARTG listing current and accurate?
- Sponsor obligations understood and met?
- Annual charges paid and up to date?
- Conformity assessment certificates current?
- Compliance with Essential Principles demonstrated?
Quality Management System (ISO 13485)
QMS compliance per ISO 13485 and TGA requirements.
- ISO 13485 certification current?
- Management review conducted as scheduled?
- Internal audits completed as per schedule?
- CAPA system effective and documented?
- Risk management per ISO 14971 implemented?
Design Controls & Technical Documentation
Design and development controls for medical devices.
- Design History File complete and current?
- Design verification and validation completed?
- Technical documentation meeting TGA requirements?
- Labelling compliant with TGA and TG Order 69?
Post-Market Surveillance
Post-market monitoring and reporting obligations.
- Post-market surveillance plan documented?
- Adverse events reported to TGA within required timeframes?
- Complaint handling system effective?
- Recall/corrective action procedure documented?
- Trend analysis of complaints and incidents performed?
Manufacturing & Supply Chain
Manufacturing controls and supply chain management.
- Manufacturing site audited and approved?
- Supplier qualification and monitoring in place?
- Product traceability from raw materials to distribution?
- Sterilisation process validated (if applicable)?
Clinical Evidence & Safety
Clinical evidence and ongoing safety evaluation.
- Sufficient clinical evidence supporting safety and performance?
- Clinical evaluation report current?
- Biocompatibility testing per ISO 10993 documented?
- Benefit-risk analysis documented and acceptable?
- Additional observations and actions required
Related Healthcare Checklists
- Australia Pathology Lab Safety Checklist (NPAAC)
- Australia Blood Bank Compliance Checklist (TGA)
- Australia Veterinary Practice Safety Audit Checklist
- Veterinary Practice Safety and Regulatory Compliance Checklist
- Australia Dental Practice Safety Checklist (ADA Guidelines)
- Australia Mental Health Facility Inspection Checklist
- Australia Ambulance Vehicle Pre-Trip Check
- Australia Radiology Safety & Compliance Checklist
Related Clinical Compliance Checklists
- Joint Commission Readiness - FREE Download
- HIPAA Compliance Audit - FREE Download
- OSHA Healthcare Compliance - FREE Download
- Surgical Instrument Sterility - FREE Download
- Blood Bank Quality Control - FREE Download
- Radiology Equipment QA - FREE Download
- Endoscope Reprocessing - FREE Download
- Central Line Bundle Checklist - FREE Download
- Ventilator Bundle Checklist - FREE Download
- Catheter Associated UTI Bundle - FREE Download
Why Use This Australia Medical Device Audit Checklist (TGA)?
This australia medical device audit checklist (tga) helps healthcare teams maintain compliance and operational excellence. Designed for quality manager / regulatory affairs officer professionals, this checklist covers 28 critical inspection points across 6 sections. Recommended frequency: annually.
Ensures compliance with Therapeutic Goods Act 1989, TG (Medical Devices) Regulations 2002, Essential Principles, ISO 13485, ARTG Requirements. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Australia Medical Device Audit Checklist (TGA) cover?
This checklist covers 28 inspection items across 6 sections: ARTG Registration & Compliance, Quality Management System (ISO 13485), Design Controls & Technical Documentation, Post-Market Surveillance, Manufacturing & Supply Chain, Clinical Evidence & Safety. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed annually. Each completion takes approximately 40-55 minutes.
Who should use this Australia Medical Device Audit Checklist (TGA)?
This checklist is designed for Quality Manager / Regulatory Affairs Officer professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.