Australia | Regulatory Market Profile
Updated January 1, 2023
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.
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.
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).
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.
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.
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.
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
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
Sterility
Biological safety and biocompatibility
Quality assurance techniques for animal tissues and their derivatives
Australia Medical Device Registration Fees
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
$1,416
Class IIb
$1,098
Class IIa
$1,098
Class I - sterile and measuring function
$575
Class I - other
$575
All classes of IVD devices
$1,098
Application for medical device priority applicant determination (medical devices and IVD devices)
$11,118
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
AIMD
$1,394
Class III
$1,394
Class IIb
$1095
Class IIa
$1095
Class I - sterile and measuring function
$749
Class I - other
$103
All classes of IVD (excluding Class 4 in-house IVDs, which have no fee)
$807
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
$4,350
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
$16,000
$4,000
Type of application audit - IVD Devices
Annual fee
Class 1 and Class 2 IVDs
$7,387
Class 3 and Class 4 IVDs (other than devices to which item 1.14C applies)
$22,387
Class 4 in-house immunohematology reagent IVDs
$16,621
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