The periodic renewal process for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) is essential to ensure continued compliance with regulatory requirements. The renewal process primarily focuses on maintaining updated documentation, safety data, and device compliance with the standards established by the Hong Kong Department of Health.

Here’s an overview of the process and standards for periodic renewal:

1. Renewal Timeline

• Renewal Frequency: Medical device registrations under MDACS are valid for 5 years from the date of registration approval.

• Application Deadline: It’s recommended to start the renewal process at least 6 months before the registration’s expiration date. This allows time for any additional information, assessments, or actions required by the Department of Health.

• No Automatic Renewal: There is no automatic renewal. Manufacturers must submit a new application for renewal and undergo a review process.

2. Documents and Information Required for Renewal

The renewal application typically requires the following documents and updated information:

• Updated Technical Documentation: The manufacturer must submit updated technical files for the device, which includes:

  • Design and development files

  • Risk management documentation

  • Clinical evaluation data (including post-market surveillance results, if applicable)

  • Any changes made to the device during the past registration period

  • New testing or clinical data, if relevant

• Updated Manufacturing Records: Evidence of ongoing Good Manufacturing Practices (GMP) compliance, including:

  • Manufacturing process updates

  • Quality control procedures and any updates to those processes

  • Compliance with applicable international standards, such as ISO 13485

• Post-Market Surveillance Data: Submission of the results of post-market surveillance (PMS), which should include:

  • Data on device performance in the market (adverse events, complaints, etc.)

  • Any corrective or preventive actions taken as a result of post-market observations

• Adverse Event Reports: Documentation of any reported adverse events or incidents related to the device since the last registration period, along with evidence of corrective actions or risk mitigation strategies.

• Quality Management System (QMS) Update: A summary of any changes to the Quality Management System (QMS) that may affect device manufacturing or compliance.

• Updated Labeling: Any updates to the device's labeling or Instructions for Use (IFU) must be submitted to ensure they remain compliant with the regulatory standards and include relevant safety and usage information.

• Re-certification of Compliance: Manufacturers may need to provide evidence that the device still complies with relevant international standards (such as ISO 14971 for risk management, ISO 13485 for QMS, etc.).

3. Submission of Renewal Application

• Where to Submit: Renewal applications should be submitted through the MDACS portal or Department of Health website, depending on the process in place at the time.

• Fee Payment: There will likely be a fee for the renewal application, which must be paid at the time of submission. Ensure that the fee is paid according to the current fee structure established by the Hong Kong Department of Health.

4. Evaluation and Review

• Department of Health Review: The Hong Kong Department of Health will evaluate the submitted renewal application, ensuring that the device continues to meet the regulatory requirements. This process may involve a review of updated technical documentation, adverse event reports, and post-market surveillance data.

• Possible Inspection: Depending on the device's risk classification and any changes since the last registration, the Department of Health may request additional inspections or audits. These could include inspections of the manufacturing facility or product testing.

• Approval Process: If the renewal application is complete and meets all regulatory standards, the Department of Health will approve the renewal. If issues arise during the review, the manufacturer may be required to address them before approval.

5. Notification of Renewal

• Renewal Approval: Once the renewal process is complete, the manufacturer will be notified of the successful renewal of the medical device registration.

• Updated Registration Certificate: After approval, the manufacturer will receive an updated registration certificate for the medical device. The device’s registration will remain valid for another 5 years from the renewal approval date.

6. Post-Renewal Compliance

• Continuous Compliance: After obtaining renewal, the manufacturer must continue to comply with the regulatory requirements of MDACS, including:

  • Maintaining post-market surveillance records

  • Reporting adverse events

  • Updating technical files and QMS as needed

  • Submitting any additional documents or changes to the Department of Health as they occur

• Re-certification and Ongoing Surveillance: The manufacturer should continue to meet the standards for Good Manufacturing Practices (GMP) and maintain an active vigilance system to monitor the safety and performance of the device in the market.

7. Key Considerations for Renewal

• Timeliness: Ensure that the renewal application is submitted on time (at least 6 months before expiration) to avoid any lapse in registration.

• Device Changes: Be prepared to provide evidence of compliance with regulatory standards for any changes made to the device, including its design, intended use, or manufacturing processes.

• Post-Market Data: Post-market data, such as adverse event reports and corrective actions, must be thoroughly reviewed and up-to-date to demonstrate the continued safety and efficacy of the device.

Standards to Follow for Renewal

• ISO 13485: For Quality Management System (QMS) compliance.

• ISO 14971: For risk management of medical devices.

• ISO 14155: For clinical investigations of medical devices.

• IEC 60601-1 (for electrical medical devices) and other relevant safety standards.

• ISO 10993 (biocompatibility) where applicable.

Summary of Key Steps for Renewal:

1. Start the renewal process early (at least 6 months before expiration).

2. Prepare and submit updated documentation, including technical files, manufacturing records, post-market surveillance data, adverse event reports, and any necessary corrective actions.

3. Pay applicable renewal fees.

4. Undergo any necessary evaluations or inspections requested by the Department of Health.

5. Receive the updated registration certificate if the renewal is approved.

6. Continue to maintain compliance with MDACS regulations and post-market surveillance requirements throughout the next registration period.

By following these procedures and maintaining up-to-date documentation and records, manufacturers can ensure that their Class IV medical devices remain in compliance with the regulations of the Hong Kong MDACS.

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