After obtaining Class I medical device registration with the Australian Therapeutic Goods Administration (TGA), it’s important to comply with several ongoing regulatory obligations to ensure that your product remains compliant and legally available on the market. Here’s a list of key points to consider:

1. Post-Market Obligations

After registration, ongoing post-market activities are required to ensure the continued safety and performance of the device.

• Post-Market Surveillance:

  • Implement a plan for monitoring the performance of your device in the market. This includes gathering information from users, reporting adverse events, and keeping track of any potential issues.
  • The TGA may request updates on the safety and performance of your device as part of its post-market review process.

• Adverse Event Reporting:

  • If any adverse events or issues arise related to your device (e.g., safety concerns, malfunctions), you must report them to the TGA promptly. This is part of your obligations under the Therapeutic Goods Act.
  • Use the Incident Reporting and Investigation Scheme (IRIS) for reporting these events to the TGA.

2. Annual Charges

• Annual ARTG Listing Fees:
  • You are required to pay an annual charge to maintain the listing of your Class I device in the Australian Register of Therapeutic Goods (ARTG). This fee is approximately AUD 1,080 (as of 2024).
  • Failure to pay this fee may result in the cancellation of your device’s registration.

3. Labeling Compliance

• Maintain Labeling Accuracy:
  • Ensure that your device labeling and instructions for use remain accurate and up to date. Labeling must continue to comply with the TGA’s labeling requirements, including warnings, usage instructions, and the manufacturer’s details.
  • Any changes to the labeling must be reflected in the ARTG if they affect safety or performance.

4. Device Modifications

• Notify the TGA of Significant Changes:
  • If you make any changes to your device after registration (e.g., changes in design, intended use, or manufacturing process), you may need to notify the TGA. Major changes that affect the device’s safety or performance might require a new submission or amendment to your current registration.
  • For Class I devices, minor changes that don’t impact safety or effectiveness may not require new registration, but you should still document any changes in your internal records.

5. Sponsor Obligations

• Australian Sponsor Responsibilities:
  • If you are a foreign manufacturer and have appointed an Australian sponsor, that sponsor remains responsible for:
    • Regulatory compliance with the TGA.
    • Acting as the primary point of contact with the TGA.
    • Handling any adverse event reports or requests for information.
  • Ensure regular communication with your sponsor to stay aligned on compliance matters.

6. Keep Records and Documentation

• Maintain Technical Documentation:
  • You must retain your technical documentation (e.g., risk management files, clinical evidence, Declaration of Conformity) throughout the product’s lifecycle. The TGA may request to review these documents as part of post-market audits or compliance checks.

7. Marketing and Advertising Compliance

• Adhere to Advertising Regulations:
  • Ensure that all advertising and promotional materials for your device comply with the Therapeutic Goods Advertising Code. This code outlines the legal requirements for promoting therapeutic goods to consumers and healthcare professionals.
  • Do not make misleading claims about the device’s safety, performance, or regulatory status.

8. ARTG Inclusion

• Maintain ARTG Inclusion:
  • Regularly check your device’s inclusion status on the ARTG to ensure it remains current and valid. If any issues arise with your registration (e.g., non-payment of fees or failure to comply with post-market requirements), your device’s ARTG entry may be suspended or canceled.

9. Device Recalls

• Be Prepared for Recalls:
  • If your device is found to be non-compliant or poses a safety risk, the TGA may require you to recall the product from the market. Ensure that you have a recall plan in place and can execute it effectively if required.
  • Voluntary recalls are also possible if you identify issues internally before the TGA intervenes.

10. Global Regulatory Changes

• Stay Informed About Regulatory Changes:
  • The TGA’s regulatory framework may evolve over time, so it’s essential to stay updated on any changes that may impact your device. Regularly review TGA updates, regulatory notices, and guidance documents to ensure ongoing compliance.
  • If you sell your device in other countries, be aware of international regulatory changes that could also affect your Australian registration.

Summary of Post-Registration Responsibilities

1. Post-Market Surveillance: Monitor device performance, report adverse events.
2. Annual Charges: Pay annual ARTG listing fees.
3. Labeling Compliance: Ensure labeling remains accurate and compliant.
4. Device Modifications: Notify TGA of significant changes.
5. Sponsor Obligations: Ensure your Australian sponsor remains compliant.
6. Record Keeping: Maintain technical documentation and records.
7. Advertising Compliance: Follow TGA advertising guidelines.
8. ARTG Inclusion: Maintain ARTG listing status.
9. Recalls: Be prepared for product recalls if necessary.
10. Regulatory Updates: Stay informed about TGA and global regulatory changes.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn