After submitting an application for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), there are several ongoing regulatory requirements and obligations that must be met to maintain compliance. These include post-approval monitoring, quality control, labeling requirements, and reporting obligations. Below are the key regulations and requirements that manufacturers must adhere to after the application process:

1. Post-Market Surveillance (PMS)

Post-market surveillance (PMS) is a critical requirement for all medical devices, especially Class IV devices, due to their high-risk nature. Manufacturers must establish and maintain a robust PMS system to monitor the device’s safety and effectiveness once it is on the market.

Key Elements:

• Reporting Adverse Events: Manufacturers must have mechanisms in place to report any adverse events or device-related incidents to the Hong Kong Department of Health (DH). This includes events such as malfunction, injury, or death related to the device’s use.

• Periodic Safety Update Reports (PSUR): Class IV devices may require manufacturers to submit PSURs at regular intervals. These reports should include details of the device’s performance in the market, including any incidents, corrective actions, and plans for continued monitoring.

• Corrective and Preventive Actions (CAPA): If safety or performance issues arise, the manufacturer must take corrective actions to prevent further issues and report these actions to the DH.

2. Quality Management System (QMS) Compliance

Once the device is on the market, the manufacturer is required to maintain an ongoing Quality Management System (QMS) that is compliant with ISO 13485 standards. The QMS should be actively used for:

• Continuous monitoring of product quality.

• Internal audits to ensure compliance with regulatory requirements.

• Documentation control, ensuring all records related to device design, manufacturing, and post-market activities are up-to-date and accessible for inspection.

Regular internal audits should also be conducted to ensure ongoing compliance with Hong Kong MDACS requirements. Audits will help in identifying any potential risks to product safety and compliance early.

3. Device Labeling and Instructions for Use (IFU)

Labeling and IFU requirements continue to apply post-registration, and the manufacturer is required to ensure that:

• The labeling on the device packaging and labeling materials remains compliant with Hong Kong’s requirements. This includes ensuring the device name, intended use, warnings, precautions, and contraindications are clearly visible.

• The IFU should continue to be updated and include necessary safety information, usage guidelines, and the correct procedures to follow. It must also meet language requirements, including being in both English and Chinese.

• UDI (Unique Device Identification): If applicable, the device should comply with the UDI system, and its UDI number must be displayed on the packaging, making it easier for tracking and identification in case of issues.

4. Reporting of Product Changes

Any modifications or changes made to the medical device after registration, such as design changes, manufacturing process adjustments, or changes to the intended use, must be reported to the Hong Kong Department of Health.

Key Reporting Considerations:

• Substantial Changes: If a significant change impacts the device’s safety or performance, it may require a new registration application or reclassification. Manufacturers must submit updated documentation to the DH for review and approval before implementing such changes.

• Non-Substantial Changes: For minor changes that do not significantly impact the device's safety or efficacy, manufacturers may be required to submit a change notification or provide updated documentation demonstrating continued compliance with regulatory standards.

5. Post-Market Vigilance

Manufacturers must engage in ongoing vigilance activities to ensure that any issues related to device safety are quickly identified and addressed. These activities typically include:

• Monitoring adverse events and complaints related to the device.

• Tracking device performance through customer feedback, sales data, and incident reports.

• Reporting incidents to the DH in accordance with the Hong Kong Medical Device Regulations.

6. Recalls and Field Safety Corrective Actions (FSCA)

In the event of a safety issue or malfunction that could harm patients, the manufacturer may be required to initiate a recall of the device or issue field safety corrective actions (FSCAs).

Steps for Managing Recalls:

• Notify the Hong Kong Department of Health (DH) of any planned recall or FSCA, providing details of the issue, the affected products, and the corrective actions taken.

• The DH may also require a public recall notice or require the manufacturer to take corrective actions to prevent further distribution of the unsafe device.

7. Periodic Reporting and Updates

Depending on the device and the specifics of the registration, manufacturers may be required to submit periodic updates to the Hong Kong Department of Health regarding the device’s performance and safety.

• Annual Reports: These might include updates on adverse events, corrective actions taken, and the device’s continued compliance with regulations.

8. Manufacturing Inspections

Hong Kong’s Department of Health has the authority to conduct inspection audits of manufacturing facilities to ensure that the device is being produced in accordance with Good Manufacturing Practice (GMP) standards.

• If the device manufacturer is based outside of Hong Kong, these inspections may take place at the manufacturer’s production facilities.

9. Recertification

Class IV medical devices may be subject to recertification after a certain period or upon the introduction of significant modifications to the device. Manufacturers should be aware of the timelines and processes for recertification under the Hong Kong MDACS regulations.

10. Handling Complaints

Manufacturers are responsible for managing complaints related to the device’s performance. Complaints may arise from healthcare providers or patients, and manufacturers should have processes in place for:

• Investigation of complaints.

• Root cause analysis to determine if the device caused the issue.

• Corrective actions if necessary.

• Documentation of each complaint and its resolution.

Conclusion

Once a Class IV medical device is approved for sale in Hong Kong under the MDACS, the manufacturer must continue to comply with rigorous post-market obligations, including post-market surveillance, vigilance activities, and reporting of any changes or adverse events. Maintaining compliance with regulatory standards, updating technical documentation, and ensuring proper labeling and safety protocols are critical to retaining market authorization.

Do you need further clarification on any of these post-registration requirements or specific guidance on how to implement them for your device?

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