Yes, annual review is required for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS). This review is part of the ongoing regulatory requirements to ensure that the registered device continues to meet the necessary safety, quality, and performance standards throughout its lifecycle. Here are the key points regarding the annual review process:

1. Regulatory Compliance Maintenance

• Annual review ensures that the manufacturer continues to comply with Hong Kong’s regulatory requirements for medical devices. It is essential to maintain an active registration status, and any changes to the device or its manufacturing processes need to be reported.

• Manufacturers must provide updates on any new clinical data, adverse events, or post-market surveillance results that could affect the device’s safety or effectiveness.

2. Post-Market Surveillance

• As part of the annual review, manufacturers are required to submit post-market surveillance reports. These reports must include information on the device’s performance in the market, including any adverse events or complaints received, and any corrective actions taken.

• If any significant issues are identified during the year, the manufacturer may need to update the device’s labeling, instructions for use, or even take action to address a potential product recall.

3. Documentation and Data Updates

• The manufacturer may be required to submit updated documentation that reflects any changes to the device, including changes in manufacturing processes, design modifications, or updates to risk management practices.

• If there are any significant updates to clinical data or if the device has undergone further clinical trials or testing, this should be reported as part of the annual review.

4. Reassessment of Safety and Efficacy

• The annual review process also includes a reassessment of the device’s safety and efficacy based on new data, regulations, or standards. If any changes occur in the regulatory landscape, manufacturers will need to ensure that the device remains compliant with the updated standards.

5. License Renewal

• While the device's registration certificate does not expire, the annual review is a necessary step for maintaining the validity of the device's registration. The Department of Health (DH) may require the manufacturer to renew the registration or submit an updated application if significant changes have occurred.

6. Inspections and Audits

• During the annual review, the Hong Kong Department of Health (DH) may also request inspections or audits of the manufacturing facilities to ensure continued compliance with regulatory requirements, including adherence to ISO 13485 standards and good manufacturing practices (GMP).

Key Considerations for Annual Review:

• Timeliness: Ensure that all required documents and updates are submitted within the specified timelines to avoid delays or penalties.

• Monitoring and Reporting: Keep track of any adverse events, complaints, or other issues that arise during the device's use, as these must be included in the annual review.

• Regulatory Changes: Stay informed about changes in regulatory requirements in Hong Kong or internationally, and ensure the device continues to meet these updated standards.

Conclusion

While there is no specific "expiration" of the registration for Class IV medical devices under Hong Kong MDACS, the annual review is a critical regulatory requirement to maintain the device's approved status. This process helps ensure that the device remains compliant with safety and quality standards throughout its lifecycle and provides a mechanism for continuous monitoring and improvement.

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