One of the most sought-after markets for medical devices globally is the Australian market. With the regulatory reforms and increasing demand for innovative products, the Australian medical device market expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing the medical device approval process in Australia.

There is a growing demand for full-range medical devices in Australia, especially for devices intended to treat and manage age-related diseases, disability, and chronic pain, and improve recovery times.

• Currently, Australia imports more than 80% of devices from countries like the USA, Europe, and Japan. This growing demand creates an opportunity for overseas manufacturers.
• Also, Australia has a simple and agile regulatory process for medical device marketing, making it a preferred destination for many manufacturers.

Before moving into the medical device regulatory, let’s understand the difference between medical devices (Non-IVD) and IVD devices.

Medical devices & IVD devices

• Medical devices (MD) are the equipment intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body and generally achieve their purpose by physical, mechanical, or chemical action.
• In-vitro diagnostic devices (IVD) are pathology tests and related instrumentation for testing on human samples where the results assist in clinical diagnosis or in making decisions concerning clinical management. IVD medical devices can also be intended for use by a health professional at the point of care or used by laypersons for self-testing.

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Medical device Regulations in Australia

The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and Ageing, oversees the medical device regulations in Australia.

Medical and IVD medical devices are assessed against the Essential Principles (EP) and in line with their intended purpose and risk-based classification.

What TGA looks into relating to the safety and performance of the medical device (Essential Principles)

Six general Essential Principles apply to all devices.

• Use of medical devices not to compromise health and safety
• Design and construction of medical devices to conform to safety principles
• Medical devices to be suitable for the intended purpose
• Long-term safety
• Medical devices are not to be adversely affected by transport or storage
• The benefits of medical devices outweigh any side effects

There may be more requirements depending on the device design and its intended purposes, such as manufacturing, biological safety, electrical safety, sterilization, biological origin materials, mechanical and radiation safety, and labeling requirements.

Before moving into the regulatory process, let’s look at the classification of medical devices and IVD devices concerning their risk and intended purpose.

Classification of medical devices

Class	Risk	Examples
Class I	Low	Surgical retractors, tongue depressors
Supplied sterile (Class I) Incorp. a measuring function) (Class I) Class IIa	Low-medium	Hypodermic needles, suction unit Medicine cup with specific units of measurement Digital or infrared thermometers
Class IIb	Medium-high	Lung ventilator, blood bags, condoms
Class III	High	Heart valves, major joint replacement implants, devices containing medicines or tissues, cells or substances of animal, biological or microbiological origin
AIMD (Active Implantable Medical Devices)	High	Implantable defibrillator

Classification of IVD devices

Class	Risk Level/Description	Examples
Class 1 IVD	No public health risk or low personal risk	Sample collection container Microbiological culture media
Class 2 IVD	Low public health risk or moderate personal risk	Pregnancy and fertility self-testing kits Cholesterol test
Class 3 IVD	Moderate public health risk or high personal risk	Tests to detect a sexually transmitted disease Human genetic tests
Class 4 IVD	High public health risk	Blood donor screening tests for HIV Test for Ebola, COVID-19

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Medical device approval process in Australia

The approval process for medical devices in Australia involves two steps

• Step 1: Pre-market assessment
  • Conformity assessment
• Step 2: Market authorization and inclusion in the ARTG
  • Preliminary assessment of applications for ARTG inclusion
  • TGA assessment of applications for ARTG inclusion

Now let’s discuss each step involved in the market approval of the medical device in detail.

Step 1: Pre-market assessment (Conformity Assessment)

Any application made by the sponsor for the inclusion of a medical device in the ARTG shall include information as required in the application form, including Conformity Assessment certification from TGA or comparable overseas regulators such as EU, and possibly evidence of product assessment (depending on the classification of the device).

What is the Conformity Assessment?

Conformity Assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the Essential Principles. The manufacturer should select appropriate Conformity Assessment procedures based on the classification of the medical device.

The manufacturer is responsible for demonstrating compliance with the Essential Principles (EP) before applying for a Conformity Assessment (CA) or inclusion on the Australian Register for Therapeutic Goods (ARTG).

What is CE marking?

The Conformitè Europëenne (CE) Mark is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA)

For medical devices that already have CE marking

• Devices that have already earned CE certification from European Notified Bodies (ENB) will have more advantages in meeting TGA requirements. 
• The approval process and timeline depend on the quality, and completeness of technical documentation, and preparedness to provide any additional information required by TGA during the review process.

Medical Device Single Audit Program (MDSAP)

• Australia is one of the key players in the Medical Device Single Audit Program (MDSAP) development and was one of the partners participating in the program, so manufacturers participating in the MDSAP and intending to place their devices on the Australian market will have a special advantage. 
• The TGA considers the MDSAP audit reports in its conformity assessment. 

Step 2: Market authorization and inclusion in the ARTG

The TGA may approve the inclusion of a device in the ARTG based on the information provided in the application received, or TGA may select an application for audit assessment.

The audit of the application may involve a review of information such as the labeling, instructions for use, technical documentation and advertising materials for the device, clinical evidence, risk management documentation for the device, reports from the notified bodies, or microbiology assessment.

Foreign manufacturers

Foreign manufacturers who intend to market their medical devices in Australia should comply with additional requirements while submitting the documents required for the registration process to the TGA.

Devices are regulated and reviewed based on the risk associated with the device, broadly classified as Low-risk devices and moderate to high-risk devices.

Regulatory flow for low-risk devices (Class I)

Class-I medical devices do not have a measuring function and don’t require to be sterile. Some Class 1 IVD medical devices not for self-testing or point-of-care can be auto-included in the ARTG.

• The sponsors for these devices must fill in and submit an electronic medical device application to the TGA.
• The Application shall include the intent purpose statement, classification, and Global Medical Device Nomenclature (GMDN) code and pay the application fee.
• However, upon request, the sponsor may have a copy of the manufacturer’s declaration of conformity for the device and be able to provide it to the TGA on request together with the other documentation relevant to the device (e.g. labeling, instruction for use, evidence of the performance of the device, and advertising material).
• The TGA may approve or reject the application. If approved by TGA, an Australian Register of Therapeutic Goods (ARTG) listing number will be issued (ARTG Certificate of Inclusion) and your listing will be included in the ARTG database on the TGA website.
• Now you can market your device in Australia.

Regulatory flow for other devices (Class I – sterile and measuring, IIa, IIb, III)

• The applicant shall have the current technical file or design dossier and Australian Declaration of Conformity ready for submission
• The sponsor submits the Manufacturer’s Evidence (e.g., CE Marking certificate) in TGA Business Services (TBS) system for TGA’s review and acceptance.
• The Application shall include the intended purpose statement, classification, and Global Medical Device Nomenclature (GMDN) code. Pay the application fee.
• The applicant should submit a copy of the Conformity Assessment certification issued to the manufacturer by an appropriate conformity assessment body or a declaration of conformity made by the manufacturer (if relevant). The TGA may approve or reject the application.
• If TGA approves, then an Australian Register of Therapeutic Goods (ARTG) listing number will be issued (ARTG Certificate of Inclusion) and your listing will be included in the ARTG database on the TGA website.
• Now you can market your device in Australia.

Post-market assessment of medical devices

• Once a device is approved, manufacturers are expected to continue to monitor the performance and safety of their devices and ensure continued compliance with the Essential Principles.
• The manufacturer shall review the performance, safety, and benefit-risk assessment of the device.
• TGA performs post-market monitoring to ensure the ongoing regulatory compliance and safety of medical devices supplied to the Australian market.

Fee for the medical device approval process in Australia

A one-time listing fee is required to include a medical device on the ARTG, as well as yearly fees for the renewal of the ARTG registration. Fees are updated each fiscal year.

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