Quality assurance for medical devices in Australia
Medical device sponsors and manufacturers in Australia must maintain a quality management system that meets the Essential Principles and conformity assessment procedures under the Therapeutic Goods (Medical Devices) Regulations 2002. This guide covers the 10 core quality assurance obligations for devices entered in the ARTG.
Coverage
Australian sponsors, manufacturers and notified bodies of medical devices — including in-vitro diagnostic devices, Class I to Class III devices, active implantable devices and software as a medical device.
Legal basis
Therapeutic Goods Act 1989 (Cth), particularly Chapter 4. Therapeutic Goods (Medical Devices) Regulations 2002, sch 1 (Essential Principles) and sch 3 (Conformity Assessment Procedures). ISO 13485 (harmonised QMS standard) and TGA Essential Principles guidance.
The obligations
Implement a compliant QMS
Maintain a quality management system (typically aligned with ISO 13485) that addresses design, production, distribution and post-market requirements across the product lifecycle.
Demonstrate the Essential Principles
Demonstrate that each device meets the 15 Essential Principles for safety and performance, with evidence documented in a technical file.
Classify devices correctly
Classify the device (Class I, Is, Im, IIa, IIb, III, AIMD or IVD class) using the rules in the Regulations, as this drives the conformity assessment pathway.
Use appropriate conformity assessment
Apply the correct conformity assessment procedure, including TGA or comparable overseas regulator certificates as evidence for ARTG inclusion.
Conduct design controls and risk management
Run design controls and risk management aligned with ISO 14971, with verification and validation records retained for each design change.
Maintain a post-market surveillance plan
Operate a post-market surveillance plan that captures complaints, field performance data and periodic safety updates for regulator review.
Report adverse events to the TGA
Report device-related serious adverse events, near misses and trend notifications to the TGA within the mandated timeframes.
Control changes and variations
Notify the TGA of ARTG variations — including manufacturer, sponsor, intended use and significant design changes — before supply continues.
Manage unique device identification
Prepare for TGA Unique Device Identifier requirements for labelling and device registry submissions as they commence for each class.
Retain QMS records for the specified period
Retain QMS and technical file records for the life of the device plus the period specified in the Regulations, and make them available for TGA inspection.
What happens if you do not comply
Non-compliance can trigger TGA suspensions or cancellations of ARTG entries, conformity assessment certificate suspensions, civil penalties of up to approximately $1.565 million per contravention for individuals and $15.65 million for corporations, and criminal offences.
Reporting requirements
Sponsors must submit annual reports, adverse event reports, PMS reports, ARTG variation notifications and responses to TGA post-market reviews or audits.
What firms should do today
- Map the QMS to ISO 13485 and the Essential Principles with a gap matrix
- Maintain a per-device technical file and post-market surveillance plan
- Run a quarterly management review covering complaints and CAPAs
- Track ARTG variations through a controlled change register
- Keep TGA Unique Device Identifier readiness on the roadmap
Compliance with Quillio
Quillio reviews supply, manufacturing and distribution agreements to align QMS responsibilities, change controls and post-market surveillance data flow with TGA obligations. See /resources/security.
This guide is general information about medical device quality assurance in Australia — not legal or regulatory advice. Sponsors should work with a specialist regulatory lawyer and QMS consultant.
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