For Class I medical device registration with the Australian Therapeutic Goods Administration (TGA), there is no formal periodic renewal process similar to what you might find in other regulatory jurisdictions. Once your device is listed on the Australian Register of Therapeutic Goods (ARTG), the registration remains valid as long as you continue to meet certain ongoing regulatory requirements. However, you must comply with several key obligations to maintain your ARTG listing. Below are the standards and processes you must follow to ensure the ongoing validity of your Class I device registration.

1. Annual Charges

• Annual ARTG Listing Fee:

  • There is an annual charge for maintaining the listing of your Class I device on the ARTG, which is around AUD 1,080 (as of 2024). This fee must be paid each year to keep your device's registration active.
  • If you fail to pay the annual fee, the TGA may cancel your device’s registration, and you would need to go through the process of re-listing the device.

• Notification of Invoices:

  • The TGA will issue an invoice for the annual fee. Ensure that the sponsor (if applicable) or the manufacturer pays the invoice by the due date to avoid the suspension or cancellation of your registration.

2. Post-Market Surveillance and Reporting

• Post-Market Surveillance Obligations:

  • Even though no formal renewal process is required, you must comply with post-market surveillance activities. This includes monitoring the performance and safety of the device once it is on the market.
  • You are required to report any adverse events or serious safety issues related to the device to the TGA under the Incident Reporting and Investigation Scheme (IRIS).

• Adverse Event Reporting:

  • Any significant safety-related incidents, device malfunctions, or injuries caused by the device must be promptly reported. Failure to do so could lead to regulatory action, including potential delisting.

3. Maintain Technical Documentation

• Ongoing Technical Documentation:

  • The technical documentation submitted during the initial application must be maintained and updated as needed. This includes:
    • Declaration of Conformity.
    • Risk Management Files (in compliance with ISO 14971).
    • Design, manufacturing, and quality control documentation.
    • Labeling and Instructions for Use (IFU) documentation.

• Readiness for TGA Audits:

  • The TGA may conduct post-market audits or request to see your technical documentation at any time. Therefore, you should ensure that your records are always current and accessible.

• Changes to Device Documentation:

  • If there are any changes to the device, such as modifications in design, manufacturing processes, or intended use, you must update the technical documentation accordingly. Significant changes may also require notifying the TGA (see below).

4. Notification of Changes

• Changes in Device or Manufacturing:

  • If there are any significant changes to your device, such as alterations to its design, function, manufacturing process, or labeling, you must notify the TGA.
  • Examples of significant changes include:
    • Changes affecting the device’s safety or performance.
    • A change in the intended use of the device.
    • A change in the device's manufacturing site or the quality management system.

• Declaration of Conformity Updates:

  • If your device undergoes significant changes, you may need to issue a new or updated Declaration of Conformity to reflect the modifications and ensure ongoing compliance with the Essential Principles.

5. Quality Management System (QMS)

• Ongoing Compliance with ISO 13485:
  • While Class I devices are low-risk, manufacturers are expected to adhere to a Quality Management System (QMS) aligned with ISO 13485. This ensures that your manufacturing processes continue to produce devices that meet safety and quality standards.
  • Ensure that your QMS is regularly reviewed and updated, especially if there are changes in the production process, suppliers, or materials used in the device.

6. Labeling and Advertising Compliance

• Therapeutic Goods Advertising Code:
  • All marketing and advertising for your Class I device must remain compliant with the Therapeutic Goods Advertising Code. This includes:
    • Accurate representation of the device’s performance and safety.
    • Clear labeling of the manufacturer’s information, batch number, and intended use.
  • Avoid misleading claims about the device’s effectiveness, capabilities, or regulatory status.
• Periodic Labeling Review:
  • Review your device’s labeling and Instructions for Use (IFU) to ensure they remain compliant with TGA requirements. Update the labeling if there are any changes to the device or if new safety information becomes available.

7. ARTG Listing Updates

• Maintaining ARTG Information:

  • If there are any changes to the sponsor, manufacturer, or key product details, you must update the ARTG entry for your device.
  • Changes that must be reported include:
    • Changes to the manufacturer’s details or site.
    • Changes to the Australian sponsor (if the manufacturer is outside Australia).
    • Any significant modifications to the device or its intended use.

• Cancellation of Listing:

  • If you decide to discontinue the supply of your device in Australia, you or your sponsor must notify the TGA, and the device will be removed from the ARTG. You must also inform the TGA if the device is no longer being manufactured.

8. Periodic Safety Updates

• Provide Safety and Performance Updates (If Applicable):
  • Although not typically required for Class I devices, in some cases, the TGA may request periodic safety or post-market performance updates. This is more common for higher-risk devices, but it is something to be prepared for, particularly if there are complaints or adverse event reports related to your device.

9. Recalls or Corrective Actions

• Product Recalls:

  • Be prepared to initiate recalls or corrective actions if your device is found to be non-compliant or if it poses a safety risk. You must notify the TGA of any voluntary recalls or corrective actions.

• Corrective Action Reporting:

  • If the TGA requests a corrective action or product modification, you must submit a plan outlining how you intend to address the issue, including timelines and steps to prevent future occurrences.

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