Australian Regulatory Guidelines for Medical Devices (ARGMD)

The Australian Regulatory Guidelines for Medical Devices (ARGMD) is an index of Guidance relating to medical devices in Australia. This includes the Essential Principles, conformity assessment, classification, post market and more.

Medical device inclusion

Find out what's needed to import, export, and supply medical devices in Australia:

• Medical device inclusion process
• Manufacturer evidence
• What classification is my device?
• Fees and charges
• Global Medical Device Nomenclature (GMDN) Terms
• The use of GMDN codes for IVD medical devices in Australia

Global Medical Device Nomenclature (GMDN) Term

GMDN provides regulators, manufacturers, and others with a common language to communicate and share information. A GMDN is needed to apply for ARTG inclusion. 

Essential Principles

The Essential Principles are legislative requirements.

They relate to safety and performance characteristics of medical devices.

These also include in vitro diagnostic (IVD) devices.

We have created an Essential Principles checklist. This tool helps medical device manufacturers prove compliance with the Essential Principles.

Conformity assessment

Conformity assessment is the systematic and ongoing examination of evidence and procedures.

Conformity assessment is how manufacturers show that their devices (including IVDs) comply with the Essential Principles.

Medical device manufacturers (including IVDs) need:

• appropriate documentation demonstrating compliance of the device with the Essential Principles
• class 1 IVD and class I medical device manufacturers must make a declaration of conformity
• higher class medical device manufacturers need an appropriately certified quality management system
• higher class medical device manufacturers need either a TGA-issued conformity assessment certificate or conformity assessment documents from a comparable overseas regulator.

The following contain information for manufacturers:

• Using assessments from comparable overseas regulators for medical devices
• Conformity assessment overview
• Conformity assessment overview (IVDs)
• Application for conformity assessment certificates
• Changing or transferring conformity assessment certificates
• Declaration of conformity templates (medical devices)
• Reduction of assessment fees for medical devices
• Understanding conformity assessment for in-vitro diagnostic medical devices (IVDs)
• Completing conformity assessment for immunohaematology reagents (IHRs)

Other information relevant to submitting evidence to support the application:

• Standard orders and medical devices
• Defining joint replacement medical devices and ancillary medical devices
• In Vitro Fertilisation (IVF) solutions
• Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure
• Supplying electronic instructions for use (eIFU) for medical devices
• Supplying or manufacturing medical devices containing poisons
• Clinical evidence guidelines: medical devices
• Understanding regulation of software-based medical devices
• Complying with regulatory requirements for system or procedure packs
• Custom-made medical devices
• Defining joint replacement medical devices and ancillary medical devices
• HIV testing in Australia
• Classification of IVD medical devices
• Delays in medical device conformity assessment recertification
• Personalised medical devices (including 3D-printed devices)
• Regulatory affairs consultants
• Search the ARTG
• Search products cancelled from the ARTG at the sponsor's request
• Varying entries in the ARTG
• Changing the sponsor/transferring therapeutic goods

Australian Register of Therapeutic Goods (ARTG)

Therapeutic goods that can be legally supplied in Australia are listed in the ARTG.

• Search the ARTG
• Search products cancelled from the ARTG at the sponsor's request
• Varying entries in the ARTG
• Changing the sponsor/transferring therapeutic goods

Post market

As long as a medical device is in the ARTG, it has to keep meeting all requirements.

All manufacturers and sponsors of medical devices have to follow mandatory requirements.

Here's what sponsors and manufacturers need to know about post-market:

• Distribution records
• Report an adverse event
• Post market reviews
• Annual reports
• Recalls
• Annual Charge Exemption (ACE) scheme