Australian Regulatory Guidelines for Medical Devices (ARGMD)

The Australian Register of Therapeutic Goods (ARTG) is a comprehensive document that provides crucial information on the import, export, and supply of medical devices within Australia. It outlines the legislative framework governing medical devices, including various requirements for regulatory compliance, safety, and performance.

Key Elements of the ARTG

• Legislative Requirements
  • ARTG Inclusion: A medical device must be included in the ARTG to be legally supplied in Australia, and it must meet all regulatory, safety, and performance requirements.
  • Global Medical Device Nomenclature (GMDN): Devices are classified using the GMDN term to standardize their description.
• Manufacturer and Sponsor Responsibilities
  • Mandatory Compliance: Manufacturers and sponsors must adhere to ongoing regulatory obligations, such as:
    • Monitoring device performance.
    • Investigating failures or deviations.
    • Implementing corrective actions as necessary.
  • Post-Market Responsibilities:
    • Maintain distribution records and ensure traceability.
    • Report adverse events to the appropriate authorities.
• Post-Market Reviews
  • Compliance Dashboards and Audits: Regular reviews are conducted to ensure ongoing compliance with regulations and to assess the device’s safety and performance in the market.
• Annual Reports and Ongoing Obligations
  • Manufacturers and sponsors must submit annual reports to maintain their standing in the ARTG and demonstrate continued compliance.
• Conformity Assessment
  • Conformity assessments must be conducted to demonstrate compliance with safety and performance principles outlined in the ARTG. These assessments ensure that devices meet the necessary standards before they are marketed.

By following these guidelines, manufacturers and sponsors can ensure that their medical devices meet the stringent regulatory requirements of the ARTG, safeguarding patient safety and device effectiveness throughout their lifecycle.

Region: Australia
Source: https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd