After obtaining Class A medical device registration under Hong Kong MDACS (Medical Device Administrative Control System), there are several important considerations to ensure compliance with ongoing regulatory requirements and maintain the status of the registered device. Here’s a summary of key points to note:

1. Maintain Device Records and Documentation

• Ongoing Records: You are required to maintain accurate and up-to-date records of your medical device, including details about manufacturing, distribution, labeling, and any changes made post-registration.

• Documentation Updates: If there are any modifications to the device, its labeling, or its intended use, you must update the registration details with the Hong Kong Department of Health (DH).

2. Post-Market Surveillance and Vigilance

• Monitor Device Performance: Even for Class A devices, monitoring the device’s performance in the market is essential to identify any potential risks, adverse effects, or safety concerns that may arise after the device is used in the field.

• Adverse Event Reporting: If any adverse events or malfunctions occur, you must follow the necessary procedures to report these to the Hong Kong Department of Health. Prompt reporting is required for devices that may present a risk to patient safety.

• Safety Monitoring: Implement post-market surveillance to ensure the device remains safe and effective. This can involve collecting data on its use and performance in clinical or practical settings.

3. Comply with Labeling and Instructions for Use (IFU) Requirements

• Ensure that your device continues to meet the labeling requirements set by MDACS. This includes providing up-to-date instructions for use (IFU), product specifications, and safety information in both English and Traditional Chinese.

• Changes to Labeling: If there are any changes to the device or its instructions, the labeling should be updated accordingly and the changes should be communicated to MDACS if necessary.

4. Renewal and Ongoing Compliance

• Class A Device Registration Duration: MDACS registration typically does not have a fixed renewal period for Class A devices. However, you must ensure continuous compliance with Hong Kong’s regulatory framework.

• Re-registration: If there are significant changes in the device, such as a change in its intended use, design, or manufacturer, you may need to apply for re-registration.

• Updates to Registration Information: If there are any changes to your contact information, such as a change in your local responsible person (LRP) or manufacturer, update the MDACS registration records.

5. Good Manufacturing Practice (GMP) and Quality Control

• Ongoing Compliance with GMP: Ensure your manufacturing processes continue to adhere to Good Manufacturing Practices (GMP) to guarantee that your devices remain of high quality.

• Quality Management System: Even though Class A devices do not require ISO 13485 certification, implementing a quality management system can be beneficial for managing ongoing compliance and device quality.

6. Distribution and Importation Requirements

• Ensure that your device complies with all importation and distribution regulations in Hong Kong. If you are working with distributors or importers in Hong Kong, ensure they are aware of their responsibilities regarding device handling, distribution, and reporting.

• If your device is imported into Hong Kong, you may need to comply with importation licensing rules and maintain records related to the distribution chain.

7. Stay Updated on Regulatory Changes

• Regulatory Updates: The regulatory environment for medical devices in Hong Kong is subject to change. Regularly check for any updates to the Medical Device Ordinance (Cap 593), MDACS, or other relevant guidelines to ensure that your device remains compliant.

• New Standards: New or updated international and local standards may apply to your device, so it’s important to stay informed about changes in ISO standards, IEC standards, or any other relevant regulations.

8. Prepare for Inspections

• Market Surveillance and Inspections: The Hong Kong Department of Health may conduct market surveillance, including inspections of your manufacturing processes and records. Be prepared to provide documentation related to device safety, quality, and performance.

• Ensure that your device is ready for potential inspections by maintaining proper records and adhering to all regulatory requirements.

9. Record and Report Adverse Events and Recalls

• Adverse Event Reporting: If a device malfunction or adverse event occurs, you must promptly report the incident to the Hong Kong Department of Health.

• Device Recall: If your device poses a significant risk to health, you may need to initiate a recall. A clear procedure for managing recalls and communicating with stakeholders (patients, healthcare providers, distributors) should be in place.

10. Local Responsible Person (LRP) Obligations (If Applicable)

• If you are a manufacturer based outside Hong Kong, you must appoint a Local Responsible Person (LRP) to handle regulatory and compliance matters in Hong Kong. The LRP must act as your official representative, ensuring that all regulatory requirements are met.

📌 Key Notes:

• Compliance Continuity: Ensure that you continuously comply with MDACS requirements, including post-market surveillance, vigilance, and any changes to labeling or device functionality.

• Device Modifications: Inform MDACS about any changes to the device that could affect its safety or regulatory status.

• Proactive Monitoring: Actively monitor the safety and performance of your device, maintaining vigilance to prevent issues or risks from arising.

By staying proactive in monitoring compliance, keeping updated documentation, and maintaining effective communication with Hong Kong authorities, you can ensure continued success and regulatory adherence for your Class A medical device in Hong Kong.

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