After obtaining Class I medical device registration with the Australian Therapeutic Goods Administration (TGA), manufacturers and sponsors must comply with various regulations and ongoing requirements to maintain the device's status on the Australian Register of Therapeutic Goods (ARTG). Here's a detailed breakdown of the key regulatory obligations:

1. Post-Market Surveillance and Monitoring

• Post-Market Surveillance: Manufacturers and sponsors must implement a system to monitor the safety, performance, and quality of the device after it has been marketed. This includes:
  • Tracking and recording user feedback and complaints.
  • Monitoring any potential adverse events or issues associated with the device.
  • Investigating product failures or performance issues to prevent recurrence.
• Adverse Event Reporting:
  • Any adverse events or serious performance issues must be reported to the TGA under the Incident Reporting and Investigation Scheme (IRIS).
  • Incidents involving injury or death must be reported promptly, as they could result in a product recall or further investigation by the TGA.

2. Maintaining ARTG Listing

• ARTG Inclusion Maintenance: Once registered, your device will remain on the ARTG, but this listing must be maintained:
  • Annual Charges: An annual fee must be paid to keep the device listed on the ARTG (around AUD 1,080 as of 2024). Failure to pay this fee can result in the cancellation of your registration.
  • Ongoing Compliance: Ensure the device continues to comply with the TGA’s regulatory requirements, including any changes to standards or regulations.

3. Reporting Changes to the Device

• Notify TGA of Significant Changes:
  • If there are major changes to your device, such as modifications in the design, intended purpose, or manufacturing process, you must notify the TGA. Some changes may require a new submission or re-evaluation of the device's compliance.
  • Examples of significant changes that require notification include:
    • Changes that affect the safety or performance of the device.
    • A change in the device's intended use or labeling.
    • A change in the device’s manufacturing site or quality system.

4. Adherence to Advertising and Marketing Rules

• Therapeutic Goods Advertising Code: All advertising and marketing materials must comply with the Therapeutic Goods Advertising Code. This includes:
  • Truthfulness in Claims: Advertising must not contain misleading or unverified claims about the device’s safety, performance, or regulatory status.
  • Prohibition on False Endorsements: Avoid making false or unauthorized endorsements, especially related to therapeutic outcomes.
  • Clear Information: Ensure that all promotional material provides clear and accurate information about the device’s purpose, limitations, and potential risks.

5. Labeling and Instructions for Use (IFU)

• Maintain Accurate Labeling:
  • Ensure that the device labeling continues to comply with TGA requirements, including the name of the device, the manufacturer’s details, batch number, expiration date (if applicable), and any necessary warnings or precautions.
  • If there are any changes to the labeling or instructions for use, the updated information should reflect any changes in device performance or regulatory status.

6. Quality Management System (QMS) Compliance

• Ongoing QMS Compliance:
  • Even though Class I devices are considered low-risk, the manufacturer must continue to follow good manufacturing practices (ideally certified under ISO 13485). This ensures that the device is consistently produced in accordance with quality and safety requirements.
  • If you change your QMS (such as changing suppliers or modifying quality controls), ensure that the changes are documented and do not affect the device’s compliance with regulatory requirements.

7. Record Keeping and Documentation

• Maintain Technical Documentation:
  • You must retain your technical documentation, such as the Declaration of Conformity, risk management files, and clinical evidence (if applicable) throughout the device’s lifecycle.
  • These documents should be readily available for inspection if the TGA requests them during post-market audits or investigations.
• Compliance Audits:
  • The TGA may conduct post-market audits or reviews to ensure that your device remains compliant with the Essential Principles and other regulatory requirements.
  • Be prepared for potential audits, and ensure that all documentation is up to date and accurate.

8. Post-Market Corrective Actions

• Product Recalls or Corrective Actions:
  • If the device is found to be non-compliant or poses a safety risk, the TGA may request a recall or corrective action.
  • Manufacturers and sponsors should be prepared to execute recalls swiftly and effectively. In the event of a voluntary recall, notify the TGA immediately and follow the required procedures.

9. Post-Market Safety Reporting

• Periodic Safety Updates:
  • Depending on the nature of the device, the TGA may require periodic safety updates or post-market performance reports. These are typically required for higher-risk devices but may also apply in certain situations for Class I devices, especially if there is a history of adverse events or complaints.
• Continuous Risk Management:
  • Continue to update your risk management file (aligned with ISO 14971) as new information becomes available. This file should reflect any emerging risks, as well as how they are being mitigated in practice.

10. Stay Informed of Regulatory Updates

• Monitor Regulatory Changes:
  • The TGA’s regulatory framework may change over time, including updates to the Essential Principles, product standards, or other regulatory expectations.
  • Regularly review updates and guidance from the TGA to ensure that your device continues to comply with any new regulations or changes in the regulatory landscape.
• International Regulatory Alignment:
  • If you sell your device in other countries, stay informed about international regulatory developments, as these may impact your Australian registration, especially if the TGA aligns with global standards.