After obtaining Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), there are several important considerations and ongoing obligations that manufacturers must follow to maintain compliance with regulatory requirements. Here are key aspects to keep in mind:

1. Post-Market Surveillance (PMS) and Vigilance System

Once a Class IV device is on the market, manufacturers are required to have a Post-Market Surveillance (PMS) system in place to ensure ongoing safety and effectiveness. This includes:

• Monitoring the Device's Performance: Continuous tracking of the device’s safety and performance once it is sold in Hong Kong. This can involve collecting feedback from healthcare professionals, patients, and other users.

• Adverse Event Reporting: Manufacturers must establish a system to report any adverse events or device malfunctions to the Hong Kong Department of Health (DH).

  • Adverse events could include incidents where the device causes harm or does not function as expected.

  • Prompt reporting is critical, and regulatory authorities may request corrective or preventive actions based on the reported incidents.

• Field Safety Corrective Actions (FSCA): If any safety concerns arise post-market, manufacturers may be required to carry out corrective actions, such as recalls, modifications, or updates to the device.

  • A recall must be reported to the authorities and conducted in compliance with local laws and MDACS regulations.

2. Quality Management System (QMS) Maintenance

• Continuous Compliance with ISO 13485: The manufacturer’s Quality Management System (QMS) must remain compliant with ISO 13485. This includes performing regular internal audits, reviewing processes for device manufacturing, and keeping documentation up-to-date.

• Regular Audits: The Hong Kong Department of Health may conduct audits or inspections to ensure that the manufacturer continues to comply with the standards outlined in the initial registration.

3. Updating Registration Information

If there are any changes to the device or the manufacturer’s details, it is critical to update the MDACS registration. Some situations that would require updating include:

• Changes in Device Design or Composition: If there are any significant modifications to the device that affect its safety or performance, the device may need to be re-evaluated and re-registered.

• Manufacturing Changes: Any changes to the manufacturing process or the manufacturer’s facility that could impact the quality or compliance of the device should be reported to the authorities.

• Change in Manufacturer Details: If there are changes in the manufacturer’s name, address, or contact information, these details should be promptly updated in the registration.

4. Periodic Review and Renewal of Registration

• Registration Renewal: While MDACS registration may not have an explicit renewal date, manufacturers must ensure that their registration remains valid and meets all regulatory requirements. The Department of Health may request periodic updates or evidence of continued compliance.

• Ongoing Compliance: The manufacturer is responsible for ensuring that all aspects of the device’s lifecycle, including post-market surveillance, clinical data, and technical documentation, are maintained up to date.

5. Market Surveillance by Hong Kong Authorities

The Hong Kong Department of Health (DH) conducts regular market surveillance to ensure that medical devices placed on the market continue to comply with safety and performance standards. Manufacturers should be prepared for potential market checks, which may involve:

• Product Inspections: Random or scheduled inspections of devices already on the market to verify compliance with the MDACS registration and regulatory requirements.

• Testing and Sampling: The authorities may carry out additional testing or sampling to ensure the ongoing safety of Class IV devices. Manufacturers should cooperate with these activities and provide access to necessary documentation and device samples.

6. Communication with Local Responsible Person (LRP)

If the manufacturer is located outside of Hong Kong, they must maintain regular communication with their Local Responsible Person (LRP) in Hong Kong. The LRP is the point of contact for the Hong Kong Department of Health and handles all regulatory communications on behalf of the manufacturer. They play a crucial role in:

• Reporting Adverse Events: The LRP assists in reporting adverse events and coordinating corrective actions.

• Regulatory Updates: Ensuring that the manufacturer is aware of any changes in regulations or requirements from the Department of Health.

7. Labeling and Marketing Compliance

• Maintaining Accurate Labeling: The labeling and packaging of Class IV medical devices must continue to comply with regulatory requirements, including appropriate usage instructions, warnings, and contact information.

  • Labels must include the device's name, model, intended use, manufacturer’s details, and any specific instructions required for safe use.

  • Translations: Labels must be provided in both English and Chinese.

• Advertising and Promotion Compliance: Ensure that all marketing, advertising, and promotional materials are consistent with the registered claims and approved indications for use. Any deviation from the registered details could lead to regulatory scrutiny or penalties.

8. Maintain Documentation for Inspections or Audits

• Documentation Maintenance: Manufacturers should keep all technical documentation, clinical data, risk management files, and post-market surveillance records up to date and accessible for inspection by regulatory authorities.

  • Regularly review and update the clinical evaluation reports, risk management documentation, and post-market surveillance plans.

• Internal Audits: Perform internal audits and reviews of processes to ensure that all aspects of compliance are met. Ensure that any corrective actions identified during audits are implemented promptly.

9. Training and Education

• Staff Training: Manufacturers should ensure that staff members involved in the manufacturing, quality control, and regulatory functions are regularly trained on the latest regulations, quality management systems, and safety protocols.

• Stakeholder Education: Educate distributors, healthcare professionals, and other stakeholders on the proper use, maintenance, and potential risks associated with the device.

10. Stay Informed About Regulatory Changes

• Regulatory requirements may change, and manufacturers must stay informed about any updates in the MDACS guidelines or global regulations (such as ISO or IEC standards).

• Regularly monitor the Hong Kong Department of Health for announcements and new regulations related to medical devices.

Conclusion

After obtaining Class IV medical device registration under Hong Kong MDACS, manufacturers are responsible for maintaining compliance with ongoing regulatory obligations, including post-market surveillance, updating registration information, ensuring the quality management system remains intact, and being prepared for inspections and audits. Proactive management of these obligations will help ensure continued compliance and minimize regulatory risks.

Would you like further details on any specific aspect of post-registration obligations or the MDACS process?

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