Navigating Australia’s Medical Devices Regulations: What MedTech Companies Need to Know

Understanding Australia’s Regulatory Framework

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices and in vitro diagnostic (IVD) devices in Australia. The organization’s primary role is to protect patient safety and promote innovation by setting clear guidelines for device approval and monitoring.

Detailed requirements for compliance including device classification, conformity assessment procedures, and criteria for device authorization are outlined in the Therapeutic Goods (Medical Devices) Regulations. Additional guidance is published in the Australian Regulatory Guidelines for Medical Devices (ARGMD).¹ This serves as a key reference for manufacturers and their sponsors.

Complying With TGA’s Essential Principles

Companies are responsible for generating and maintaining clinical, design, and manufacturing evidence that demonstrates their devices comply with TGA’s Essential Principles.²

The following six Principles provide manufacturers a framework for ensuring that their devices meet the necessary performance and safety standards before market release:

Medical devices ensure patient health and safety.
Design and production methods conform with safety principles.
Medical devices perform according to their intended use.
Devices are designed and produced in a way that ensures long-term safety.
Transport and storage methods do not adversely affect device characteristics and performance.
Medical device benefits outweigh any undesirable effects.

TGA Essential Principles Checklist

The Essential Principles checklist is a template to help you identify the safety and performance requirements that apply to your device. Manufacturers should complete and maintain a checklist for each new medical device conformity assessment application.

Click here to access the downloadable template.

Image-Screen capture of instructions on filling out the checklist

All devices are evaluated against the Essential Principles throughout their entire lifecycle. Below are examples of the types of evidence manufacturers can gather to demonstrate compliance:^³

Details of design and construction:

General description of the device’s intended purpose and users
Specifications, protocols, procedures, and details of design and development methods and technologies used for manufacturing, packaging, storage, handling, and distribution
Procedures for measuring and monitoring the safety, performance, and quality of your device
Procedures for servicing (if applicable)
Procedures for assuring the medical device is sterile (if applicable)

Risk management reports:

Risk analysis
Risk evaluation
Identification of residual risks
Controls of known and foreseeable risks

Characterization studies:

Qualitative or quantitative information obtained through observation, measurement, tests, or any other means used to assess how the device operates

Clinical evidence:

A compilation of published and unpublished scientific literature, both favorable and unfavorable, of your device including:
- Information about the hazards and associated risks from the use and potential misuse of the device
- Information about the performance of the device, including techniques used to examine whether devices of that kind achieve their intended purpose

Product labeling:

Copies of labels, packaging, patient information, and instructions for use (IFUs)

Image-Team of Engineers and Scientists Work on Robotics Exoskeleton Prototype.

Quality Management System Requirements

Manufacturers must implement a comprehensive quality management system (QMS) which includes processes, procedures, and records pertaining to the design, production, labeling, packaging, and clinical evaluation of the device. The QMS should align with TGA’s Essential Principles and adhere to the QMS requirements outlined in ISO 13485.

Key QMS elements include:

Creation of a quality policy and manual
Management team responsibilities
Resource management (i.e., infrastructure, equipment, and supply chain)
Detailed product specifications and guidance on intended use
Defined plan and processes for ensuring document control and protection of sensitive information
Product realization—planning, design, development, production, and service provision
Development of a risk management plan
Processes for post-market surveillance
- Managing complaints
- Identifying and addressing nonconformances
- Reporting to regulatory authorities

Sections

Why MedTech Companies Are Tapping Into the Australian Market

Understanding Australia’s Regulatory Framework

Complying With TGA’s Essential Principles

TGA Essential Principles Checklist

Quality Management System Requirements

Device Classifications

Conformity (Pre-Market) Assessment of Medical Devices

Market Authorization (Inclusion in the ARTG)

Post-Market Surveillance

TGA Post-Market Vigilence

Key Steps for TGA Medical Device Certification and Market Approval

Accelerate Your Path to Compliance With Arena QMS

Device Classifications

The Therapeutic Goods (Medical Devices) Regulations provide a set of rules to help manufacturers classify their device.

Medical Device Classification Criteria

Australia’s medical device classification system mirrors that of the EU. Devices are categorized according to their intended use and risk they pose to patients.

The risk level is based on the following device properties:⁴

Degree of invasiveness
Duration and location of use
Whether it relies on an energy source to operate

Medical Device Classification	Risk	Examples
Class I	Low	Surgical retractors Tongue depressors
Class Is (Supplied Sterile)	Low-Medium	Hypodermic needles Suction units
Class Im (Incorporating a Measuring Function)		Measuring cups with specific units of measurement Digital or infrared thermometers
Class IIa		Hearing aids Infusion pumps Contact lenses
Class IIb	Medium–High	Lung ventilators Blood bags
Class III	High	Heart valves Joint replacement implants Cells or substances of animal, biological, or microbiological origin
AIMD (Active Implantable Medical Devices)	High	Implantable defibrillators

Medical Device Classification

Class I Low Risk
• Surgical retractors
• Tongue depressors

Class Is (Supplied Sterile) Low-Medium Risk
• Hypodermic needles
• Suction units

Class Im (Incorporating a Measuring Function) Low-Medium Risk
• Measuring cups with specific units of measurement
• Digital or infrared thermometers

Class IIa Low-Medium Risk
• Hearing aids
• Infusion pumps
• Contact lenses

Class IIb Medium–High Risk
• Lung ventilators
• Blood bags

Class III High Risk
• Heart valves
• Joint replacement implants
• Cells or substances of animal, biological, or microbiological origin

In Vitro Diagnostic Device Classification Criteria

IVD devices are classified according to their intended use and the public health or personal risk that may arise from an incorrect result.⁵

IVD Device Classification	Risk	Examples
Class 1	No public health risk Low personal risk	Sample collection containers Microbiological culture media
Class 2	Low public health risk Moderate personal risk	Pregnancy and fertility self-testing kits Cholesterol tests
Class 3	Moderate public health risk High personal risk	Tests to detect a sexually transmitted disease (e.g., chlamydia, gonorrhea) Human genetic tests
Class 4	High public health risk	HIV screening tests Ebola tests

IVD Device Classification

Class 1
No public health risk
Low personal risk
• Sample collection containers
• Microbiological culture media

Class 2
Low public health risk
Moderate personal risk
• Pregnancy and fertility self-testing kits
• Cholesterol tests

Class 3
Moderate public health risk
High personal risk
• Tests to detect a sexually transmitted disease (e.g., chlamydia, gonorrhea)
• Human genetic tests

Class 4
High public health risk
• HIV screening tests
• Ebola tests

Image-Person using a pen to mark "High risk" level on the risk assessment matrix table.

Conformity (Pre-Market) Assessment of Medical Devices

Graphic-Medical Device and In Vitro Diagnostic Device Classification Criteria

A conformity assessment involves the examination of clinical data, design records, quality processes, and technical documentation to determine if the device performs as intended and conforms to TGA’s Essential Principles.

The device classification dictates the extent of the conformity assessment. Low-risk (Class I) devices typically require only a self-assessment and declaration of conformity from the manufacturer. Higher risk (Class IIb, III, or Class 4 IVD) devices require a review of the manufacturer’s QMS, clinical evaluations, and technical documentation by an Australian Conformity Assessment Body (CAB) or comparable overseas authority.

Market Authorization (Inclusion in the ARTG)

Medical and IVD devices must be added to the Australian Register of Therapeutic Goods (ARTG) to be lawfully sold in Australia. The manufacturer’s sponsor is responsible for submitting a medical device application along with a copy of the conformity assessment certificate and other supporting evidence as requested.

Post-Market Surveillance

Manufacturers are expected to continuously monitor the performance and safety of their device and ensure ongoing compliance with the Essential Principles once it is approved. This includes:

Maintenance of records pertaining to device shipments, distribution centers, end-user locations, and export countries
Reporting of field corrections, adverse events, and complaints
Submission of annual safety and performance reports

TGA Post-Market Vigilence

Post-market monitoring by the TGA includes the following:

Investigation and risk assessment of adverse event reports and complaints
Review of conformity evidence against the Essential Principles
Periodic reviews of the manufacturer’s quality management system and technical file

Key Steps for TGA Medical Device Certification and Market Approval