The periodic renewal of Class C medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) ensures that the device continues to comply with regulatory standards and remains safe and effective for use in the market. Renewal is typically required every five years, and it involves submitting updated documentation, confirming ongoing compliance with applicable standards, and paying the relevant fees. Below are the key standards, procedures, and requirements for the renewal process:

1. Renewal Timing

• Renewal Interval: The registration of a Class C medical device under MDACS is valid for five years. To avoid registration lapses, you must apply for renewal before the registration expires.
• Recommended Submission Time: It is advisable to start the renewal process and submit the application 3 to 6 months before the expiration date to allow sufficient time for review and approval by the Medical Device Control Office (MDCO).

2. Documentation Required for Renewal

The renewal application must include updated and relevant documentation to demonstrate that the device still complies with the safety and performance standards required under MDACS.

Key Documents for Renewal:

1. Updated Device Information:

   • Any changes in device design, materials, or intended use since the initial registration.
   • An updated device description and specifications (if necessary).

2. Quality Management System (QMS) Certification:

   • Evidence of ongoing compliance with ISO 13485 (or equivalent QMS standard).
   • A valid and up-to-date ISO 13485 certificate from a recognized certification body.

3. Clinical Evidence:

   • Updated clinical data or post-market studies that provide evidence of the device’s safety and effectiveness, especially if new clinical trials or studies have been conducted since the initial registration.

4. Post-Market Surveillance (PMS) Data:

   • Results from the Post-Market Surveillance (PMS) Plan, including any adverse event reports, product complaints, and any corrective or preventive actions taken during the registration period.
   • Summary of device performance data gathered through the PMS program, showing the device’s continued compliance with safety standards.

5. Adverse Event Reports:

   • A summary of all adverse events (if any) reported to MDCO during the previous registration period, and how these events were managed.
   • Reports on any corrective actions taken or recalls initiated.

6. Labeling and Instructions for Use (IFU):

   • Up-to-date labeling and Instructions for Use (IFU) documents.
   • The labeling and IFUs must remain compliant with MDACS requirements and be available in both English and Chinese.

7. Declaration of Conformity:

   • A renewed Declaration of Conformity to confirm that the device continues to meet the Essential Principles of Safety and Performance under MDACS.
   • Reference to any updated international standards (e.g., ISO, IEC) that the device complies with.

8. Conformity Assessment Certificates:

   • Updated evidence of conformity with international standards, such as CE marking, US FDA approval, or equivalent regulatory certifications from other recognized jurisdictions.
   • If there have been any changes to the certification, provide the updated certificates.

3. Application Submission Process

The renewal application must be submitted to the Medical Device Control Office (MDCO) via the specified procedure for Class C devices.

Steps to Submit the Renewal Application:

1. Prepare Renewal Documents: Compile all the required documents, including updated technical files, ISO 13485 certificate, clinical evidence, PMS data, and adverse event reports.

2. Complete the Application Form: Fill out the renewal application form (provided by MDCO) with updated information about the device and manufacturer, including any changes since the original registration.

3. Submit the Application: Submit the completed renewal application and supporting documentation to MDCO either electronically or via the specified method (check the MDCO's official website for submission guidelines).

4. Pay the Renewal Fee: Pay the relevant renewal fee for Class C device registration. The amount may vary depending on the device class and registration status. Ensure that the payment is made on time to avoid processing delays.

4. Review Process by MDCO

Once the renewal application is submitted, the MDCO will review the documentation to ensure that the device continues to meet all the necessary safety, quality, and performance standards.

• Compliance Check: MDCO will verify the continued compliance with the Essential Principles of Safety and Performance and ensure that the device meets the latest regulatory standards.
• Risk Assessment: MDCO may assess any adverse event reports or complaints filed during the previous registration period and evaluate whether any corrective actions were effective.
• Technical Review: If there are significant updates in the device’s design or functionality, MDCO may request additional technical information or evidence, such as updated clinical data or testing results.

5. Post-Renewal Obligations

After successful renewal, several ongoing obligations must be maintained, including:

1. Post-Market Surveillance: Continue to implement the Post-Market Surveillance Plan to monitor the safety and performance of the device.
2. Adverse Event Reporting: Keep reporting any adverse events related to the device to MDCO in a timely manner.
3. Compliance with Updated Standards: Ensure ongoing compliance with any new or updated international standards (ISO, IEC) or local regulatory changes.

6. Key Considerations for Renewal

• Device Modifications: If there have been any significant changes to the device since the initial registration, such as changes in materials, intended use, or design, you must ensure these changes are well-documented and reported in the renewal application.
• Timely Submission: Submitting the renewal application well in advance of the expiration date is essential to avoid registration lapses that could prevent the device from being legally marketed.
• Quality System Maintenance: Ensure that your ISO 13485 certification is up-to-date and covers the entire scope of the device’s manufacturing and distribution process.

7. Renewal Fee

The renewal of Class C medical devices requires the payment of a renewal fee to MDCO. The fee amount is typically based on the device class and may vary depending on the complexity of the review.

8. Compliance with Updated Regulations

During the registration renewal process, it is essential to ensure that the device is compliant with any new or updated MDACS guidelines or regulations. Staying informed about changes to the MDACS regulatory framework is crucial for maintaining compliance during the renewal process.