After applying for Class A medical device registration under Hong Kong MDACS (Medical Device Administrative Control System), you must continue to adhere to several important regulations and requirements to maintain compliance. These regulations cover aspects like post-market surveillance, device recall procedures, labeling updates, and reporting requirements. Here’s a detailed overview of the regulations and requirements you must follow:

1. Post-Market Surveillance (PMS)

• Ongoing Monitoring: After your device is placed on the market, you must actively monitor its safety and performance. This includes collecting information about any adverse events or problems with the device in real-world settings.

• Adverse Event Reporting: If there are any adverse events (such as malfunctions, risks to patient safety, or injuries) related to your device, you are required to report them to the Hong Kong Department of Health (DH) in a timely manner.

  • Reports should include a description of the event, the device involved, corrective actions, and any further steps taken.

  • Be aware of the timelines for reporting adverse events, as delays may lead to regulatory penalties.

• Corrective Actions: If necessary, take corrective actions to resolve issues. This may include device repairs, improvements, or safety feature updates.

2. Device Recall

• Recall Procedure: In case of a significant safety risk or a device defect that could pose harm to users, you must be prepared to recall the device from the market.

  • A recall plan should be in place to ensure the prompt removal of faulty devices from distribution channels.

  • You must inform the Hong Kong Department of Health (DH) and work with them during the recall process.

  • If necessary, you may need to notify the public and your customers about the recall and provide guidance on how to return the device.

3. Labeling and Documentation Updates

• Changes to Device Information: If there are any significant changes to the device, such as modifications to its design, performance, intended use, or manufacturing process, you may need to update your labeling, packaging, and the Instructions for Use (IFU).

• Labeling Compliance: Ensure that all labeling is up-to-date and remains in compliance with Hong Kong’s medical device regulations, including bilingual labeling in English and Traditional Chinese.

  • If you update the device's labeling or instructions, ensure these changes are properly communicated to Hong Kong regulatory authorities.

4. Regular Regulatory Reporting

• Periodic Updates to the Department of Health: While Class A devices are considered low-risk, the Hong Kong Department of Health may require periodic updates about the device's performance, especially in cases of ongoing adverse events or market recalls.

• Annual Maintenance of Registration: Depending on the regulations, you may need to perform a re-registration or update your registration periodically to ensure that all information is up-to-date and your device remains compliant.

• Changes in Manufacturing or Distribution: Any changes to the manufacturer’s information or distribution channels must be reported to the Hong Kong Department of Health.

5. Quality Management System (QMS)

• While ISO 13485 certification is not mandatory for Class A devices, maintaining an effective Quality Management System (QMS) is highly recommended to ensure compliance with good manufacturing practices (GMP) and ongoing regulatory obligations.

  • Internal Audits: Conduct regular internal audits to verify that your quality control systems are in place and working effectively.

  • Supplier Management: Ensure that all suppliers of critical components are in compliance with your QMS requirements.

6. Reporting of Import and Distribution Activities

• If your Class A device is imported into Hong Kong, importers and distributors must adhere to specific regulations related to the distribution of medical devices. This may involve:

  • Registration: Importers may need to keep records of devices being imported and ensure that they are properly registered with the Department of Health.

  • Market Surveillance: Ensure that devices continue to be safe and effective after distribution and report any incidents as needed.

7. Device Tracking and Traceability

• Maintain an effective system for tracking and tracing devices distributed in Hong Kong. This includes ensuring that you can identify where the devices are and who they have been sold to or distributed to, which is especially important if a recall is necessary.

• Ensure traceability in case of an incident or adverse event so that affected devices can be quickly identified and removed from the market.

8. Continuous Compliance with Hong Kong Regulations

• Compliance with the Medical Device Ordinance (Cap. 595): Ensure that your device continues to meet all applicable regulations under the Medical Device Ordinance and related legislative frameworks.

• Stay Updated on Regulatory Changes: The regulatory environment can change over time, so it's essential to stay updated on any changes to the Medical Device Administrative Control System (MDACS) and related guidelines that could affect your product.

9. Inspection and Audits

• The Hong Kong Department of Health may conduct inspections or audits of your facilities, documentation, or manufacturing processes to verify compliance with regulatory requirements.

• Self-Inspection: Conduct internal inspections of your processes, facilities, and records to ensure they align with regulatory expectations.

10. Continued Education and Training

• Keep your team trained and informed about regulatory updates, quality assurance procedures, and industry best practices. This is essential for maintaining compliance and for responding appropriately to any regulatory inspections or adverse events.

• Training for Distributors and Importers: Ensure that anyone involved in the distribution or sale of the device is aware of their regulatory obligations.

Summary of Post-Application Requirements:

• Post-Market Surveillance: Ongoing monitoring of device safety and performance.

• Adverse Event Reporting: Timely reporting of any issues to the Department of Health.

• Device Recall: Plan and execute recalls if necessary.

• Labeling Updates: Keep labels and documentation up-to-date.

• Regulatory Reporting: Regular updates and maintenance of registration as required.

• Quality Management: Maintain a robust QMS to ensure product quality.

• Traceability: Ensure systems are in place for product traceability.

• Compliance with Cap. 595: Ensure ongoing compliance with the Medical Device Ordinance.

• Training: Regular training for employees and distributors on regulations.

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