One of the most sought after markets for medical devices in the world is the Australian market. With the regulatory reforms and an increase in demand for innovative products, the Australian medical device market is expected to be worth more than $4.56 billion by 2025 growing at a CAGR of 10%.

There is a growing demand for a full range of medical devices and particularly for those devices which are intended to treat and manage age-related diseases, manage disability and chronic pain, and improve recovery times. However, currently, more than 80% of the medical devices used in Australia are imported from the USA, Europe, and Japan. This creates an opportunity for manufacturers from other countries to provide alternatives to these products.

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

What are the medical devices?

Medical devices (MD) are 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.

What are the IVD devices?

In-vitro diagnostic devices (IVD) are pathology tests and related instrumentation used to carry out testing on human samples where the results are intended to 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 for use by laypersons for self-testing.

Regulatory for medical devices in Australia

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

Medical devices including 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)

There are six general Essential Principles that 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 not to be adversely affected by transport or storage
  • Benefits of medical devices to outweigh any side effects

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

Before we move into the regulatory process, let’s look at how medical devices and IVD devices are classified with regard to their risk and intended purpose.

Classification of medical devices

ClassRiskExamples
Class I Low Surgical retractors, tongue depressors
Class I (supplied sterile)
Class I (incorp. a measuring function)
Class IIa
Low-mediumHypodermic needles, suction unit
Medicine cup with specific units of measurement
Digital or infrared thermometers
Class IIb Medium-highLung 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

ClassRisk level/descriptionExamples
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

Approval process

The approval process for medical devices involves two major 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 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) prior to applying for a Conformity Assessment (CA) or inclusion on the Australian Register for Therapeutic Goods (ARTG).

What is the 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 depends on the quality and completeness of the manufacturer’s technical documentation, as well as the 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 development of the Medical Device Single Audit Program (MDSAP) and was one of the partners participating in the program, so, manufacturers participating in the MDSAP and intend 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 need to 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 with broadly classified as Low-risk devices and moderate to high-risk devices.

Regulatory flow for low-risk devices (Class I)

Class I medical devices that do not have measuring function and which are not intended to be supplied sterile, and some Class 1 IVD medical devices that are not intended to be used 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 Intended 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 begin your device marketing in Australia

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

  • Sponsor shall have current Technical File or Design Dossier and Australian Declaration of Conformity ready for submission
  • Have current Technical File or Design Dossier and Australian Declaration of Conformity ready for submission
  • The sponsor submits Manufacturer’s Evidence (e.g., CE Marking certificate) in TGA Business Services (TBS) system for TGA’s review and acceptance.
  • The Application shall include includes 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 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 begin your device marketing 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 process

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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Reference

  1. https://www.tga.gov.au/sme-assist/medical-devices-regulation-introduction
  2. https://www.pharmout.net/downloads/white-paper-how-to-register-a-medical-device-in-australia.pdf
  3. https://www.regdesk.co/register-medical-device-australia/
  4. https://brandwoodckc.com/tga-process-for-conformity-assessment-in-australia-brandwood-biomedical-medical-device-regulatory/
  5. https://www.emergobyul.com/resources/market-australia