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
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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 is a Australia Medical Device Audit Checklist (TGA)?
A Australia Medical Device Audit Checklist (TGA) is a standardized inspection form used by quality manager / regulatory affairs officer to ensure consistent healthcare operations. It contains 34 inspection points organized into 6 sections. FREE PDF download - Australian medical device audit checklist aligned with TGA regulatory requirements. Covers ARTG listing, Essential Principles, post-market surveillance, adverse event reporting, and ISO 13485 quality management. Download FREE template now.
How often should I use this healthcare checklist?
This checklist is designed to be completed annually. Regular use ensures compliance with Therapeutic Goods Act 1989 and TG (Medical Devices) Regulations 2002 and helps identify issues before they become problems.
Can I download this Australia Medical Device Audit Checklist (TGA) as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 34 fields across 6 sections and typically takes 40-55 minutes to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with Therapeutic Goods Act 1989, TG (Medical Devices) Regulations 2002, Essential Principles, ISO 13485, ARTG Requirements. Following these standards protects your organization and ensures best practices.
How do I complete this healthcare inspection checklist?
Begin by completing the header fields for Company/Sponsor Name, ARTG Number(s), Audit Date, Auditor Name, State/Territory, and Device Classification. Work through each of the 6 sections, marking items Yes or No as applicable. Add notes for any issues found. The entire process takes approximately 40 to 55 minutes.
What are the key sections in this healthcare checklist?
This healthcare checklist is organized into 6 key sections: ARTG Registration & Compliance, Quality Management System (ISO 13485), Design Controls & Technical Documentation, Post-Market Surveillance, Manufacturing & Supply Chain, Clinical Evidence & Safety. Each section contains specific inspection points that quality manager / regulatory affairs officer must verify. The structured layout ensures nothing is missed during healthcare inspections and makes the process efficient, typically taking 40-55 minutes to complete.
Who should use this Australia Medical Device Audit Checklist (TGA)?
This checklist is primarily designed for quality manager / regulatory affairs officer working in healthcare operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that healthcare standards are being met. Organizations of all sizes can benefit from using this Australia Medical Device Audit Checklist (TGA) to maintain consistency and accountability.