After obtaining Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), manufacturers and importers must continue to adhere to a range of post-registration obligations to ensure ongoing compliance with regulatory standards. These include post-market surveillance, reporting requirements, and adherence to manufacturing and quality standards. Here's an overview of the key rules and requirements that must be followed:

1. Post-Market Surveillance (PMS)

• Monitoring Device Performance: After registration, manufacturers must actively monitor the performance of the device in the market to identify any emerging safety or efficacy concerns.

• Adverse Event Reporting: If any adverse events or incidents occur involving the device, they must be reported to the Hong Kong Department of Health as part of the vigilance system. This includes any serious injuries, malfunctions, or safety issues that may affect patients or users.

• Device Recall: If any issues are identified that compromise the safety or efficacy of the device, the manufacturer may need to issue a recall. A recall must be reported to the authorities, and the manufacturer must take appropriate corrective actions to prevent further risks.

• Periodic Safety Update Reports (PSUR): Manufacturers may be required to submit periodic reports to the Department of Health regarding the safety and effectiveness of the device. This ensures continuous monitoring of the device’s risk-benefit profile.

2. Vigilance and Reporting Obligations

• Incident Reporting: Manufacturers must report any serious incidents (such as injuries or device malfunctions) that occur with the device to the Department of Health. This includes incidents that could lead to death, serious deterioration in health, or a serious risk to patient safety.

• Corrective and Preventive Actions (CAPA): If an issue arises from the use of the device, manufacturers must investigate the root cause, take corrective actions, and prevent the issue from recurring. This includes revising labeling, user instructions, or device design if necessary.

• Reporting Timeframes: The reporting of serious incidents must be done within specific timeframes, typically within 10 working days of the manufacturer becoming aware of the incident.

3. Regulatory Inspections

• Manufacturing Facility Inspections: Hong Kong’s Department of Health may conduct periodic inspections of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP). Manufacturers must be prepared for these inspections and maintain up-to-date records and systems.

• Product Inspections: In addition to facility inspections, the Department may inspect individual products to verify compliance with regulatory standards.

• Quality Management System (QMS) Audits: Regular audits of the QMS will be required to ensure that it continues to meet the requirements of ISO 13485 and that the product is consistently manufactured according to approved specifications.

4. Reporting Changes in Device Design or Intended Use

• Notifying the Authorities of Changes: If there are any changes to the device’s design, intended use, manufacturing process, or labeling, these changes must be reported to the Department of Health. This includes updates to the device’s specifications, materials, or manufacturing process that may impact the device’s safety or performance.

• Re-Classification: If the changes affect the risk level of the device (e.g., moving from Class III to Class IV), manufacturers may be required to update the registration and undergo a re-evaluation.

5. Labeling and Instructions for Use (IFU) Requirements

• Ongoing Labeling Compliance: Ensure that the device's labeling and Instructions for Use (IFU) remain compliant with the regulatory requirements. Any updates to the labeling must be approved, and the IFU must reflect the device's latest design, usage, and safety information.

• Language Requirements: The labeling and IFU must be provided in English and Chinese to meet the regulatory requirements for Hong Kong.

• Post-Market Labeling Changes: If there are any significant updates related to safety or usage, these must be reflected in the labeling and communicated to the relevant parties.

6. Continuous Clinical Evaluation

• Ongoing Clinical Data Collection: For Class IV devices, especially those with higher risk profiles, manufacturers must continue to gather and evaluate clinical data regarding the device’s performance. This data should be used to update safety and efficacy profiles regularly.

• Post-Market Clinical Studies: If required by the authorities or if new concerns arise, manufacturers may need to conduct post-market clinical studies to assess the long-term safety and performance of the device.

7. Record Keeping and Documentation

• Maintain Detailed Records: Manufacturers must maintain detailed records for each registered medical device, including:

  • Design and development records

  • Manufacturing records

  • Risk management documentation

  • Clinical evaluation and testing data

  • Post-market surveillance data

  • Any corrective actions taken

• Documentation Accessibility: All documentation related to the device must be readily available for inspection by the Hong Kong Department of Health or other regulatory authorities.

8. Annual Renewals and Updates

• Registration Renewal: Medical device registration under MDACS is generally valid for 5 years. Manufacturers must ensure that they initiate the renewal process before the expiration date to avoid the device becoming non-compliant.

• Updating Device Information: If there are any significant updates or changes to the device, manufacturers must update their registration with the Department of Health. This may include changes in manufacturing, labeling, or clinical data.

9. Maintain an Authorized Representative (if applicable)

• If the manufacturer is located outside of Hong Kong, the authorized representative in Hong Kong must maintain responsibility for communication with the authorities and ensuring regulatory compliance.

• Ongoing Compliance: The authorized representative must ensure that all regulatory obligations are met, including post-market surveillance, incident reporting, and addressing any concerns raised by the Department of Health.

10. Financial and Legal Obligations

• Paying Fees: Manufacturers must remain up to date with any applicable fees related to the device’s post-market obligations, including registration renewal, inspection fees, or fees for submitting updates.

• Legal Liability: Ensure compliance with local regulations to avoid legal or financial penalties in case of non-compliance or failure to meet post-market requirements.

Key Takeaways

1. Post-Market Surveillance (PMS) and adverse event reporting are critical components to ensure the safety of the device in the market.

2. Vigilance and corrective actions must be taken in response to safety incidents or changes in the risk-benefit profile of the device.

3. Manufacturing and regulatory inspections will continue, and the device's quality management system should remain compliant with ISO 13485.

4. Labeling and Instructions for Use (IFU) must remain up-to-date and compliant with the regulations in both English and Chinese.

5. Re-registration and renewals must be planned in advance to maintain ongoing compliance.

By following these rules and requirements, manufacturers can ensure that their Class IV medical devices remain compliant with Hong Kong’s regulatory framework, promoting the continued safety and efficacy of their products in the market.

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