The periodic renewal of a Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) is essential to ensure that devices continue to meet the regulatory requirements and standards. The renewal process involves submitting updated information about the device, confirming its continued compliance with safety and performance standards, and demonstrating that any changes or updates to the device have been adequately addressed.

Standards and Procedures for Periodic Renewal of Class IV Medical Device Registration

1. Regulatory Standards for Renewal

To ensure continued market access and safety, Class IV medical devices must comply with various international and local standards throughout their lifecycle, including during the renewal process. Key standards applicable to the renewal of a Class IV medical device registration include:

• ISO 13485:2016 (Quality Management Systems): A manufacturer must maintain an effective QMS to manage and control the device’s lifecycle, from manufacturing through to post-market surveillance. This standard is crucial for device safety and performance, and it is typically required for maintaining registration and meeting regulatory standards for periodic renewals.

• ISO 14971:2019 (Risk Management for Medical Devices): Manufacturers must implement a risk management process for their devices, ensuring that any risks associated with the device’s use are identified, evaluated, controlled, and monitored throughout the device’s lifecycle.

• IEC 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance): For devices that involve electrical components or are electrically powered, compliance with the relevant IEC standards (e.g., IEC 60601) for safety and performance is necessary. Compliance with these standards may need to be verified during the renewal process.

• Hong Kong Local Regulations: The manufacturer must comply with any updates or amendments to Hong Kong’s medical device regulations. This includes changes to MDACS requirements, which could involve new documentation, procedures, or guidelines.

2. Procedures for Periodic Renewal

Step 1: Timely Renewal Application

Class IV medical device registrations typically have a set period of validity (usually 5 years). It is essential for manufacturers to submit the renewal application well in advance of the expiration date to avoid lapses in registration. The process generally follows these steps:

• Pre-Renewal Notification: The Hong Kong Department of Health (DH) may send out a notification reminder to manufacturers about the upcoming expiration of registration. However, the manufacturer is responsible for ensuring they start the renewal process early.

• Renewal Application Submission: Manufacturers must submit an application for renewal through the MDACS Online System (or through the specified submission channel). The application will typically require the submission of updated technical documents and supporting evidence, as described below.

Step 2: Update Required Documentation

During the renewal process, manufacturers are required to submit the following documents:

• Updated Technical Documentation: This should include:

  • Device description and intended use

  • Design dossier (including design, manufacture, and performance characteristics)

  • Risk management documentation (based on ISO 14971)

  • Clinical evaluation reports, if applicable, to confirm continued safety and efficacy.

• Post-Market Surveillance (PMS) Reports: Manufacturers must provide updates on the performance of the device in the market, including:

  • Adverse events reports, if any.

  • Complaint handling and resolution documentation.

  • Field safety corrective actions (FSCA) and recall history (if applicable).

• Quality Management System (QMS) Documents: Manufacturers should provide evidence of the continued maintenance of a compliant QMS, often in the form of an audit report or certification that adheres to ISO 13485.

• Updated Labeling and Instructions for Use (IFU): Manufacturers must provide updated copies of the device's labeling and IFUs, ensuring that they comply with Hong Kong requirements and are current with any new regulatory guidelines or safety information.

• Renewed Certificates: If applicable, submit updated certificates of conformity (such as CE marks, FDA approvals, or other relevant international certifications) or confirmation of ongoing compliance with applicable standards.

Step 3: Evaluation and Review by the Department of Health (DH)

Once the renewal application is submitted, the Hong Kong Department of Health (DH) will evaluate the application and supporting documentation. The review process involves the following:

• Document Verification: DH will assess whether the manufacturer has submitted all required documents and whether these documents meet the regulatory requirements.

• Safety and Efficacy Review: DH will ensure that the device continues to meet safety and efficacy standards. This may involve verifying that the device has not caused new risks or adverse events since the initial registration.

• Inspection (if needed): The DH may conduct an inspection of the manufacturing facility, particularly if there are concerns about changes in the manufacturing process or post-market performance.

Step 4: Renewal Decision

After reviewing the application, the DH will make a decision on the renewal application. If the renewal is granted, the manufacturer will receive updated registration approval for the next period (usually another 5 years). If there are issues with the renewal application, DH may request additional information or impose corrective actions before granting approval.

Step 5: Maintain Ongoing Compliance

Once the renewal is granted, manufacturers must continue to maintain compliance with Hong Kong's MDACS requirements. This includes:

• Continued Post-Market Surveillance: Ongoing PMS activities to monitor device performance in the market and ensure that any new risks are identified and mitigated promptly.

• Periodic Audits: Manufacturers may be subject to random audits or inspections from the DH during the new registration period to ensure compliance with all regulatory requirements.

• Reporting of Changes: Any significant changes to the device or its manufacturing process must be reported to the DH as part of ongoing regulatory obligations.

3. Key Considerations for Renewal

• Timely Submission: Renewal applications must be submitted before the registration expires to avoid interruption in the market access of the device. Ideally, applications should be submitted 6 months prior to the expiration date.

• Changes to Device or Manufacturing: If there have been any significant changes to the device or its manufacturing process during the previous registration period, these must be carefully documented and reported during the renewal process.

• Compliance with Updated Standards: Manufacturers should regularly review new or updated standards relevant to their device type and ensure their device continues to comply with both international and Hong Kong regulations.

• Regulatory Fees: The renewal process may involve the payment of regulatory fees, which vary depending on the type of device and the complexity of the application.

Conclusion

The periodic renewal of a Class IV medical device registration under Hong Kong's MDACS is a critical process that ensures devices remain safe and effective for use. Manufacturers must prepare by updating technical documents, maintaining an effective quality management system, and ensuring compliance with post-market surveillance requirements. Regular monitoring of regulatory changes and timely submission of renewal applications will ensure continued market access for the device in Hong Kong.

If you need further guidance on preparing your renewal application or understanding specific requirements, feel free to ask!

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