Yes, an annual review is generally required for Class III medical device registration with the Therapeutic Goods Administration (TGA) in Australia, but it can depend on specific circumstances and obligations associated with the device's registration. Here are the key points regarding annual reviews and ongoing compliance requirements:

1. Ongoing Compliance Obligations

• Post-Market Surveillance: Once a Class III medical device is registered, manufacturers are required to conduct post-market surveillance to monitor the device's performance and safety in real-world use. This includes reporting any adverse events or incidents to the TGA.

• Annual Reviews: Manufacturers are expected to perform regular reviews of their Quality Management System (QMS) and clinical data to ensure ongoing compliance with regulatory requirements. This may include assessing the effectiveness of risk management processes, updating technical documentation, and maintaining the validity of the Clinical Evaluation Report (CER).

2. Device-Specific Requirements

• Risk-Based Approach: The need for an annual review can also depend on the risk profile of the device. Class III devices, being high-risk, require more rigorous monitoring and review than lower-risk devices.

• Regulatory Changes: If there are significant changes to the regulatory framework, or if new information arises that may affect the safety or effectiveness of the device, manufacturers may need to conduct more frequent reviews or updates to their documentation and compliance measures.

3. Quality Management System (QMS)

• ISO 13485 Compliance: Manufacturers of Class III devices must maintain a QMS that complies with ISO 13485. This standard requires regular internal audits and management reviews to ensure that the system is effective and continues to meet regulatory requirements.

4. Reporting Obligations

• Adverse Event Reporting: Manufacturers are required to report any adverse events or safety issues associated with their Class III devices to the TGA within specific timeframes, which is part of the overall ongoing compliance.

5. Device Registrations and Renewals

• Device Registration Renewal: While the TGA does not explicitly mandate an "annual renewal" process for Class III devices, manufacturers must ensure that their devices remain compliant with current regulations and standards. Failure to do so may result in the device's registration being suspended or canceled.

Conclusion

In summary, while there may not be a formal annual review submission process for Class III medical devices registered with the TGA, ongoing compliance, post-market surveillance, and regular assessments of the QMS are essential. Manufacturers must actively ensure that their devices continue to meet safety and efficacy standards throughout their lifecycle, with adjustments made as necessary based on new data or regulatory updates.