Australia | Regulatory Market Profile

Australia medical device regulatory market overview

Updated January 1, 2023

Australia TGA & Related Organizations

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TGA news

Australia Medical Device Regulations & Guidance

TGA Medical Device Classifications

Medical Devices

Australia’s medical device classifications are very similar to those used in the EU under MDR.

Medical device classes:

Class I - Lowest risk classification. Examples include surgical retractors and tongue depressors.

Class IIa - Low to medium risk devices. Examples include dental drills and ultrasound machines.

Class Im - Low to medium risk devices that provide a measuring function. Examples include a medicine cup with specific units of measure.

Class IIb - Medium to high risk devices. Examples include surgical lasers and diagnostic x-rays.

Class Is - Low to medium risk devices that are provided as sterile. Examples include sterile surgical gloves.

Class III - Highest risk devices. Examples include heart valves and pacemakers.

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TGA medical device classification overview

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What classification is my medical device? (interactive tool to help classify non-IVD devices)

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What "kind of medical device" is it? (grouping like devices together)

In Vitro Diagnostic Devices

Australia classifies IVDs into 4 categories based on a set of 8 rules.

IVD classes:

Class 1 - No public health risk or low personal risk. Examples include reagents and instruments such as prepared microbiological culture media.

Class 3 - Moderate public health risk or high personal risk. Examples include equipment for tissue typing and testing for red blook cell antibodies.

Class 2 - Low public health risk or moderate personal risk. Examples include non-assay specific quality control material such as a self pregnancy test.

Class 4 - High public health risk. Examples include equipment for detecting antigens and genetic markers, along with blood screening, HIV diagnosis, and tissue donor screening.

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Classifying IVDs

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Applying classification rules

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IVD classification examples

TGA Market Requirements

The Australian regulatory system has been based on recommendations of the former Global Harmonisation Task Force (GHTF), whose principles of conformity assessment are closely aligned with relevant EU regulations. Medical devices sold in Australia require an Australian Register of Therapeutic Goods (ARTG) listing number, which requires a local authorized representative, known as a Sponsor.

Evidence of conformity assessment:

Class I (non-sterile, non-measuring) devices and Class I IVD devices can be self-certified.

For most other devices a certificate issued under an MRA (mutual recognition agreement) by a recognized notified body is sufficient to demonstrate conformity.

Declaration of Conformity to clause 7.5 of schedule 3 of the Regulations for a system or a procedure pack (see links to templates below).

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Conformity assessment overview

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Declaration of conformity templates (medical devices)

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Declaration of conformity templates (IVD devices)

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Australian Register of Therapeutic Goods (ARTG)

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Comparable overseas regulators for medical device applications

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Application for Certificate of Free Sale or Export Certificate

Application Audit:

Application audits are conducted to verify that devices submitted for inclusion in the ARTG meet relevant legislative requirements. Application audits are mandatory, except in certain cases including devices that:

have a TGA conformity assessment certificate, or

have EU MDR 2017/745 or EU IVDR 2017/746 certification that has not been suspended or revoked, or

are included in the ARTG as an export only medical device, including export only IVD medical device.

Medical devices selected for audit, including those without a mandatory audit requirement, are subject to one of two levels of audit assessment (this excludes IVD devices):

Level 1 audits require a Declaration of Conformity along with device information (such as labeling and instructions for use).

Level 2 audits require clinical evidence, a risk management report, and efficacy and performance data (along with all level 1 requirements).

For IVD medical devices there is only one type of audit assessment, sometimes referred to as a technical file review.

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Auditing of medical device, including IVD medical device, applications
(includes full list of documentation required for each audit level)

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Application audit (technical file review) of IVD medical device application

Australia Post-Market Requirements

Devices listed in the ARTG must continue to meet all regulatory requirements, safety and performance requirements, and standards required for approval. This includes maintenance of post-market surveillance and post-market vigilance systems. The TGA also requires notification of any corrective actions, recalls, new educational notifications, and any other event effecting the safety or efficacy of the medical device.

The TGA can issue post-market review notifications at any time for any medical device and utlizes a Post Market Review Compliance Dashboard to track review activities.

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Post-market review compliance dashboard - User guide

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TGA post-market reviews

Australia UDI Requirements

UDI Compliance

The Australian Therapeutic Goods Administration (TGA) has set up a technical working group to define the specific UDI labeling and data requirements, with an expected date for the regulation in January, 2023. Mandatory compliance, however, will likely not go into effect until the following year.

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Australian UDI system

Standards and Essential Principles in Australia

The TGA defines 15 Essential Principles that are based on three key pillars that medical device manufacturers, including IVD manufacturers, must have in place.

Design and construct according to safety principles and risk mitigation

Develop solutions that are state-of-the-art and best practice

Ensure that the benefit(s) of the device outweigh(s) its risks

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Essential Principles list - Safety, performance, and quality requirements

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Demonstrating compliance with Essential Principles

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Essential Principles checklist

The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by the Australian or International Standards Agency. Voluntary standards can be used as well, however, evidence must be provided to satisfy regulation requirements.

Standards commonly used by medical device manufacturers:

ISO 13485:2016 - Quality Management Systems (QMS) for medical devices

ISO 14971 - Risk management for medical devices

ISO 10993 - Biologic evaluation of medical devices

ISO 60601 - Medical electrical equipment

ISO 10282 - Single-use sterile rubber surgical gloves

Australian medical device legislation creates a system of non-mandatory medical device standards (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance with Essential Principles or conformity assessment procedures.

While not mandatory, MDSOs and CASOs are one way to establish compliance with Essential Principles and cover topics including:

Clinical evidence

Risk Management

Medical devices required to be sterile

Quality management systems and quality assurance techniques


Biological safety and biocompatibility

Quality assurance techniques for animal tissues and their derivatives

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Standards orders and medical devices

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ISO 13485:2016

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Premarket guidance and application of standards

Application fees

As of October 1, 2023, fees required to include a medical device in the ARTG are as follows. Note that application audit fees are not included here. These fees do not apply to export-only devices.

Class of Medical Devices

Application fee

Class III


Class IIb


Class IIa


Class I - sterile and measuring function


Class I - other


All classes of IVD devices


Application for medical device priority applicant determination (medical devices and IVD devices)


Annual charges

As of October 1, 2023, annual fees required to include a medical device in the ARTG are as follows (separate from initial application fees). These fees do not apply to export-only devices.

Class of Medical Devices

Annual fee



Class III


Class IIb


Class IIa


Class I - sterile and measuring function


Class I - other


All classes of IVD (excluding Class 4 in-house IVDs, which have no fee)


Application audit assessment fees

An application audit assessment fee is payable in addition to the applicable fee for some medical devices.

Type of application audit - Medical Devices

Annual fee

Level 1: Verification of sponsor's application, evidence of conformity, and aspects of compliance against essential principles


Level 2: Level 1 activities, plus in-depth technical documentation review to determine compliance with Essential Principles - Class III medical devices.

Level 2: Level 1 activities, plus in-depth technical documentation review to determine compliance with Essential Principles- All other medical devices



Type of application audit - IVD Devices

Annual fee

Class 1 and Class 2 IVDs


Class 3 and Class 4 IVDs (other than devices to which item 1.14C applies)


Class 4 in-house immunohematology reagent IVDs


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Fees and charges summary
From Jul 1, 2023

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Information & notices about TGA fees and payments