After applying for Class II medical device MDACS registration in Hong Kong, it is important to follow various regulations and requirements to ensure compliance with the Medical Device Administrative Control System (MDACS) and to maintain the device’s approved status. Below are the key regulatory requirements and obligations to be followed once the application is submitted:

1. Post-Submission Communication

• Respond Promptly to MDCO Queries: After submitting the application, you may receive requests for additional information or clarification from the Medical Device Control Office (MDCO). It is essential to respond promptly and comprehensively to avoid delays in the registration process.

• Updates and Corrections: If any of the information provided in the application changes, such as updates to labeling, manufacturing processes, or clinical data, notify the MDCO as soon as possible to keep the registration up to date.

2. Post-Market Surveillance and Vigilance

• Monitor Device Performance: After approval and market introduction, post-market surveillance (PMS) is required to monitor the ongoing safety and performance of the device. You must track and document adverse events or any potential issues that arise during the use of the device.

• Report Adverse Events: You are obligated to report any serious adverse events (SAEs) or defects that could affect patient safety or device functionality to the MDCO. These incidents must be reported within a specified time frame (e.g., 10 days for serious injuries or deaths).

• Risk Mitigation Actions: If any issues are identified during post-market surveillance, you must take appropriate actions, such as issuing a recall, providing safety alerts, or updating the device instructions and labeling.

3. Quality Management System (QMS) Maintenance

• Maintain ISO 13485 Certification: Ensure ongoing compliance with ISO 13485 (Quality Management Systems for Medical Devices) or equivalent standards. This includes maintaining a robust QMS for product design, manufacturing, and post-market activities.

• Regular Internal Audits: Conduct internal audits regularly to ensure compliance with your QMS and identify any areas for improvement.

• Corrective and Preventive Actions (CAPA): Implement a CAPA system to address any issues found during internal audits, inspections, or as part of the post-market surveillance process.

4. Device Labeling Requirements

• Ensure Compliance with Labeling Guidelines: The device’s labeling must continue to comply with Hong Kong’s MDACS requirements. This includes the inclusion of essential information such as:

  • Manufacturer details (name, address, and contact info).

  • Instructions for use (in English and/or Chinese).

  • Warnings, precautions, and any relevant contraindications.

  • Expiration date and batch/lot numbers.

  • CE mark (if applicable) and other international certifications if your device is sold outside of Hong Kong.

• Update Labeling if Necessary: If any changes occur to the device or its indications, you must update the labeling accordingly and submit the updated version to the MDCO.

5. Clinical Follow-Up

• Clinical Evaluation Reports: After registration, you are required to continue clinical evaluation of your device if necessary. This could involve further clinical trials or data collection to ensure the device’s ongoing safety and effectiveness.

• Post-Market Clinical Follow-Up (PMCF): If required, continue collecting clinical data and provide the MDCO with updates regarding the device's performance and safety post-launch.

6. Device Recalls and Corrective Actions

• Plan for Recalls: Be prepared for potential recalls if safety issues are identified. In the event of a device recall, you must:

  • Notify the MDCO and affected parties immediately.

  • Provide a root cause analysis to the MDCO and outline corrective actions to prevent future issues.

  • Retract all affected devices from the market and ensure that customers are fully informed.

• Corrective Actions: If issues are identified, initiate corrective actions to resolve them. This might include updating manufacturing processes, implementing additional quality checks, or modifying device components.

7. Periodic Renewal of Registration

• Device Registration Validity: The MDACS registration is typically valid for 5 years. You must ensure that the registration is renewed before it expires, which involves submitting updated documentation (e.g., updated labeling, new clinical data, any changes in manufacturing).

• Continued Compliance: During the renewal process, the MDCO may require a review of your QMS, clinical evidence, labeling, and post-market surveillance activities. Ensure all documentation is up to date and ready for submission.

8. Import and Distribution Compliance

• Authorized Representative Responsibilities: Your local authorized representative in Hong Kong (if applicable) must maintain accurate records of the device’s import and distribution in Hong Kong and be prepared for any regulatory inspections by the MDCO.

• Importer Documentation: The distributor or authorized representative must ensure that the proper importation records are kept and that the device is only distributed in compliance with the MDACS regulations.

9. Regulatory Inspections

• Inspections by MDCO: The MDCO may conduct inspections of your manufacturing facilities, quality system, or post-market surveillance practices to ensure ongoing compliance with regulatory requirements. Be prepared for these inspections and ensure that all relevant documentation is readily available.

• Inspection Reports: If issues are found during an inspection, you must address them promptly and may need to submit an action plan to resolve the non-compliance.

10. Changes to the Device

• Reporting Changes: If there are any changes to the device design, manufacturing process, materials, or indications for use, these must be reported to the MDCO. Depending on the type of change, you may need to submit updated documentation or undergo a new review process.

• Submit Updates: When submitting updates, ensure that you provide clear documentation outlining the changes and their impact on the device's safety, performance, and regulatory compliance.

Conclusion

After applying for Class II MDACS registration in Hong Kong, adhering to the post-market surveillance requirements, maintaining a compliant QMS, and staying vigilant about any changes to the device or its regulatory status are key to ensuring the ongoing compliance and success of your device in the market.

By following these regulatory requirements and staying up to date with MDCO guidelines, you can minimize risks, ensure patient safety, and maintain the integrity of your product throughout its lifecycle.

If you need more specific information on any of the steps, feel free to ask!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn