Quality Management Systems for Medical Devices – TGA Requirements and Guidance

Overview of QMS Requirements

Under the Therapeutic Goods (Medical Devices) Regulations 2002, manufacturers must establish, document, implement, and maintain a Quality Management System (QMS) that ensures devices consistently meet the Essential Principles for safety and performance. The TGA recognises ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes as the primary standard for demonstrating compliance with these obligations. Source: Learn about quality management systems - TGA

Core Elements of a Compliant QMS

A TGA-compliant QMS must address key processes, including:

• Risk Management: Integrated throughout the product lifecycle per ISO 14971.
• Design and Development Controls: Systematic planning, inputs, outputs, reviews, verification, validation, and transfer.
• Production and Process Controls: Validated processes, monitoring, measurement, and traceability.
• Purchasing Controls: Supplier evaluation, monitoring, and incoming inspection.
• Monitoring and Measurement: Device performance, customer feedback, and internal audits.
• Post-Market Surveillance: Complaint handling, adverse event reporting, field safety corrective actions, and vigilance reporting to TGA.
• Management Responsibility: Quality policy, objectives, management review, and resource provision.

The QMS must also incorporate Australian-specific requirements, such as reporting obligations and labelling compliance.

Scope and Applicability by Device Class

• Class I (non-sterile, non-measuring): Basic QMS elements required; self-declaration sufficient for conformity assessment.
• Class I sterile/measuring, Class IIa, IIb, III: Full QMS certification to ISO 13485 (or equivalent) is mandatory, typically evidenced by third-party certification or TGA assessment.
• Custom-made and system/devices: Specific QMS provisions apply.

Conformity Assessment and Evidence

Manufacturers must provide evidence of QMS compliance during conformity assessment:

• ISO 13485 certificate from an accredited certification body (accepted under certain conditions, e.g., MDSAP participants).
• For direct TGA assessment: detailed QMS documentation submission.
• Ongoing surveillance: periodic audits and recertification.

Practical Implementation Tips

• Align QMS procedures with both ISO 13485 and TGA-specific requirements (e.g., adverse event reporting timelines).
• Integrate risk management into all stages.
• Maintain robust documentation and records for traceability.
• Prepare for TGA audits by conducting internal mock audits.

The TGA provides detailed guidance on implementing and maintaining a QMS for medical devices, including checklists, recognised standards, and examples of acceptable evidence. Source: Learn about quality management systems - TGA

A robust QMS is fundamental to ensuring ongoing compliance, patient safety, and successful market access in Australia.