Under Hong Kong MDACS (Medical Device Administrative Control System), periodic updates for Class A medical devices are a crucial aspect of ensuring that the device remains compliant with the latest regulatory requirements. The standards and procedures for these updates are aimed at maintaining the safety, efficacy, and quality of medical devices while also ensuring that regulatory authorities have the most up-to-date information on the device.

Here are the standards and procedures for periodic updates of Class A medical device registration under Hong Kong MDACS:

1. Periodic Re-registration and Renewal

• Re-registration: Although Class A devices are considered low-risk, manufacturers are required to update or re-register the device periodically to ensure compliance with the latest regulations. Re-registration ensures that the medical device continues to meet the applicable safety and performance standards.

• Timeframe for Re-registration: Hong Kong's regulations specify the frequency of re-registration, and manufacturers must complete the process within the given timeframe. It is usually annual or biennial depending on the device type and any changes made during the previous period.

• Renewal of Registration: The re-registration process typically involves the renewal of registration by submitting updated documentation, verifying that the device is still compliant with the requirements, and confirming that no significant changes have been made since the last registration.

  • Ensure that your device's details are up-to-date, including information on manufacturers, authorized representatives, and importers (if applicable).

  • Fee Payment: Pay any applicable fees for the re-registration process.

2. Updating Device Information

• Changes in Device Information: If there have been any changes to the device, its design, intended use, performance specifications, or manufacturing process, these must be reported to the Hong Kong Department of Health (DH).

• What to Update:

  • Manufacturer Information: If there is a change in the manufacturer or manufacturer’s address, this must be updated in the registration documents.

  • Authorized Representative: If you are utilizing an authorized representative for registration in Hong Kong, their contact information and agreement must be maintained and updated.

  • Product Design or Performance: Any changes to the design, components, intended use, or technology behind the device must be documented.

  • Packaging and Labeling: Ensure that any modifications to the labeling (including the language, product descriptions, or safety warnings) are updated in the registration.

• Revised Technical Documentation: If the device’s design or safety features change, you may need to submit revised technical documentation that includes updated risk management files, clinical evaluations, and safety testing reports.

3. Submitting Updated Documentation

• Documentation Required for Updates: When submitting periodic updates, certain key documents need to be provided, similar to the initial registration process. These include:

  • Product Information: Updated technical specifications, intended use, and performance characteristics.

  • Risk Management Documentation: Including risk assessments, mitigation strategies, and reports of any adverse events or incidents.

  • Quality Management System (QMS): Confirmation that the device continues to be manufactured and handled according to ISO 13485 standards or other applicable quality standards.

  • Labeling and IFU (Instructions for Use): Ensure that updated versions of your labeling and IFU are submitted if there are any changes in product packaging or usage instructions.

  • Clinical Data or Testing: If there are any changes to the device’s claims or performance, provide updated clinical data, testing, or validation reports as necessary.

  • Adverse Event Reports: If there have been any adverse events or product recalls, submit documentation explaining the issue and the corrective actions taken.

4. Maintaining Compliance with Regulatory Changes

• Regulatory Updates: Hong Kong’s medical device regulations can change, and manufacturers are required to stay informed of any updates to the Medical Device Ordinance (Cap. 595) or MDACS guidelines. This includes new standards, updated safety guidelines, or any revisions to the regulatory framework.

  • Notification of Changes: If the regulations change during your device’s registration period, you may need to update your device’s documentation to ensure that it remains in compliance with the latest regulatory requirements.

  • Ongoing Monitoring: Keep track of updates and changes in international standards (e.g., ISO, IEC) that may impact your device’s design, performance, or safety testing requirements.

5. Post-Market Surveillance Updates

• Adverse Event and Incident Reports: Ensure that all adverse events and incidents related to your device are reported and documented according to the post-market surveillance guidelines. Any new safety concerns, performance issues, or device failures must be communicated to the Hong Kong Department of Health.

• Corrective and Preventive Actions (CAPA): If there are any safety or performance issues with the device, you must take appropriate corrective actions, which should be reflected in your updated registration documentation.

• Market Feedback: If the device is sold in other markets and there are any significant updates based on market feedback (e.g., product improvements or issue resolutions), this information should be submitted as part of your periodic update.

6. Reporting Device Discontinuation or Withdrawal

• If you decide to discontinue the device or withdraw it from the Hong Kong market, you must inform the Hong Kong Department of Health in writing, providing details on the reason for withdrawal and the date of discontinuation.

• If the device is recalled for safety reasons, ensure that you follow the recall procedures and submit a detailed recall plan to the Department of Health.

7. Fees and Payment

• Payment for Re-registration: Ensure that any applicable re-registration or renewal fees are paid. The fees may vary depending on the type of device or changes made to the registration.

• Invoices and Receipts: Keep accurate records of all payments related to the re-registration or periodic update process.

8. Maintaining Records

• Documentation Storage: Keep records of all communications with the Hong Kong Department of Health, submitted documents, and any updates made to your device registration.

• Long-Term Documentation: Retain records related to the device’s safety, performance, clinical data, and quality management systems for a minimum period (usually 5 years), as required by the Hong Kong Department of Health.

Summary of Key Steps for Periodic Updates:

• Submit updated product information (technical specifications, labeling, intended use, etc.).

• Provide revised technical documentation, if necessary, including clinical data, risk management, and testing.

• Monitor regulatory updates to ensure compliance with changes in the law and standards.

• Report adverse events and incidents and take corrective actions if needed.

• Maintain records of communications and payments for re-registration.

By following these standards and procedures, you ensure that your Class A medical device registration under Hong Kong MDACS remains valid, compliant, and up-to-date throughout its lifecycle.

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