Australian Regulatory Guidelines for Medical Devices (ARGMD)

Frequently requested information

The following pages represent the most frequently requested information about medical devices:

• Medical device inclusion process
• Declaration of conformity templates (medical devices)
• What classification is my device?
• Global Medical Device Nomenclature (GMDN) Terms
• Comparable overseas regulators for medical device applications
• Varying entries in the ARTG - medical devices and IVDs
• Changing the sponsor/transferring therapeutic goods
• Clinical evidence guidelines: Medical devices
• Personalised medical devices (including 3D-printed devices)
• Search the ARTG for all current inclusions
• Search for products that have been cancelled from the ARTG at the sponsor's request
• Fees and charges
• Regulatory affairs consultants
• Adverse event reporting
• Annual Charge Exemption (ACE) scheme

Essential Principles

You can read the Essential Principles on our Meet safety, performance and quality requirements for medical device manufacturers page.

The Essential Principles (the Principles) are legislative requirements. They relate to safety and performance characteristics of medical devices. These also include in vitro diagnostic (IVD) devices. See Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

Conformity assessment

Conformity assessment is the systematic and ongoing examination of evidence and procedures. It makes sure medical devices (including IVDs) comply with the Essential Principles. Medical device manufacturers (including IVDs) in Australia need:

• appropriate conformity assessment procedures in place for the device, and
• appropriate documentation demonstrating compliance of the device with the Essential Principles.

Evidence that a device has undergone an appropriate conformity assessment procedure must be held before a device can be included in the Australian Register of Therapeutic Goods (ARTG).

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). This means that from 28 July 2021, devices that were previously described under regulation 4.1 (those that contain medicines or materials of animal, microbial, recombinant, or human origin, and Class 4 IVDs) no longer require mandatory TGA conformity assessment certification.

For such devices (those that contain medicines or materials of animal, microbial, recombinant or human origin, and Class 4 IVDs), we will accept conformity assessment evidence issued by the TGA, EU notified bodies and Australian Conformity Assessment Bodies. See Conformity assessment certificates, changes to requirements for certain medical devices.

The following pages contain information and guidance for manufacturers who intend to apply for TGA-issued conformity assessment certificate:

• Conformity assessment overview
• Application for conformity assessment certificates
• Substantial changes affecting a TGA conformity assessment certificate and transfers of certificates
• Reduction of assessment fees for medical devices
• Essential Principles checklist (medical devices)
• Fees and charges
• Manufacturer statutory declarations
• What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
• Conformity assessment overview (IVDs)
• Conformity assessment procedures for IHRs
• Declaration of conformity templates (medical devices)

Other information relevant to submitting evidence to support the application:

• Standard orders and medical devices
• Medical devices notices and standards orders
• Device medicine boundary products
• In Vitro Fertilisation (IVF) solutions
• Requirements for the assessment of medical devices containing animal material
• Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure
• Electronic Instructions for Use - eIFU
• The Poisons Standard and medical devices
• Clinical evidence guidelines: medical devices
• Guidelines for sterility testing of therapeutic goods
• Regulation of software based medical devices
• Systems or procedure packs
• Custom-made medical devices
• Declaration of conformity templates (medical devices)
• What classification is my device?
• Defining joint replacement medical devices and ancillary medical devices
• Overview of the Regulatory Framework for IVDs
• HIV testing in Australia
• Classification of IVD medical devices
• The use of GMDN codes for IVD medical devices in Australia
• Delays in medical device conformity assessment recertification

Medical device inclusion

• Manufacturer evidence
• Declaration of conformity templates (medical devices)
• What classification is my device?
• Global Medical Device Nomenclature (GMDN) Terms
• Comparable overseas regulators for medical device applications
• Essential Principles checklist
• Fees and charges
• Clinical evidence guidelines: medical devices
• Defining joint replacement medical devices and ancillary medical devices

Post market

Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.

We have mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. These requirements facilitate the monitoring of device performance and ensure systematic investigation of failures and/or deviations in the way a device performs, to prevent an adverse event occurring again.

Information received by us once a device is included in the ARTG informs actions including:

• corrective actions including, but not limited to, changes to device design, construction and information accompanying the device
• suspension and/or cancellation of the product
• recall actions including safety alerts, and
• educational resources including website notifications.

For sponsors and manufacturers, here's information about post-market responsibilities:

• Distribution records
• Adverse event reporting - sponsors
• Report an adverse event - health professionals and consumers
• Adverse event reporting form - sponsors
• Post market reviews
• Post market review compliance dashboard
• Annual reports
• Changing the sponsor/transferring therapeutic goods
• Recalls

Contact us

Email us if you:

• would like to suggest a new area of guidance
• want to provide feedback, or
• notice missing information, broken links. 

Reporting problems

We monitor the safety of medical devices in Australia. If you experience a problem or side effect, report it to us.