After obtaining Class I IVD medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), there are several key obligations and considerations that manufacturers and distributors must be aware of to ensure continued compliance with local regulations and to maintain the device’s legal status in the market.

Key Considerations After Registration:

1. Post-Market Surveillance and Reporting

• Ongoing Monitoring: Even after registration, manufacturers must actively monitor the device’s performance in the market. This includes tracking its safety and effectiveness through post-market surveillance activities. Such activities can include:
  • Collecting user feedback.
  • Monitoring reports of adverse events or device failures.
  • Conducting clinical follow-up (if applicable).
• Adverse Event Reporting: If any serious incidents or adverse events related to the device occur (e.g., patient harm or device malfunction), the manufacturer is required to report these incidents to the Hong Kong Department of Health in a timely manner, typically within 15 days for serious events.
• Corrective Actions: Manufacturers must have processes in place to address any issues identified through post-market surveillance, which may involve product recalls, device modifications, or updated labeling.

2. Annual Renewal

• Class I IVD registration is generally valid for 5 years, after which manufacturers must submit an annual renewal to maintain their registration status.
  • Renewal Process: While Class I devices are lower risk and do not require extensive documentation upon renewal, manufacturers must ensure that their device remains compliant with any regulatory updates or new standards.
  • Document Updates: Any changes to the device (e.g., design, intended use, labeling, or manufacturing processes) may require submission of updated documentation.

3. Changes to the Device or Manufacturer

• If there are any significant changes to the registered device, such as modifications to the design, intended use, or labeling, the manufacturer must notify the Department of Health.
  • For example, changes to the device’s materials or manufacturing process that could affect safety or performance may require a new registration or an amendment to the existing registration.
• Changes to the manufacturer or distributor (e.g., change of business address, authorized representative) must also be reported.

4. Quality Management System (QMS) Maintenance

• It’s important to maintain an up-to-date Quality Management System (QMS) that meets the standards (e.g., ISO 13485) throughout the lifecycle of the device.
  • Internal Audits: Regular internal audits and quality control checks should be conducted to ensure ongoing compliance with safety, performance, and regulatory requirements.
  • Documentation Control: Keep records of all QMS activities, including device design, manufacturing processes, and risk management actions. Ensure that these records are available for inspection by the authorities if needed.

5. Labeling and Packaging Compliance

• Ensure that the labeling and packaging of the device remain in compliance with the regulations. This includes ensuring that the instructions for use (IFU) are updated whenever necessary.
• Any changes to the labeling must be evaluated to ensure they remain consistent with the intended use and regulatory requirements.

6. Distribution and Market Access

• Devices can only be marketed and distributed in Hong Kong if they have been properly registered under MDACS. Manufacturers must ensure they are using authorized channels for the distribution of their IVD device.
• For importers and distributors, ensure that they are registered with the Hong Kong Department of Health as well, and comply with all distribution and post-market requirements.

7. Product Recalls (If Applicable)

• In case of any safety concerns, defects, or non-compliance with regulatory standards that may pose a risk to users, manufacturers must have a recall procedure in place.
• A product recall process should be initiated if a device is found to be unsafe or does not meet the regulatory requirements.
• Manufacturers must promptly notify the Hong Kong Department of Health of the recall and take necessary actions to protect public health.

8. Advertising and Promotion Compliance

• All marketing and promotional materials related to the Class I IVD device must comply with the regulations outlined by the Hong Kong Department of Health.
• The device must only be advertised and promoted for the intended use as registered. Misleading or incorrect claims could lead to penalties or removal from the market.

9. Document Retention and Record Keeping

• Manufacturers are required to retain records related to the device for a period of time, typically 5 years after the device is no longer marketed.
• These records can include design history files, production records, labeling, testing results, and post-market surveillance data.

10. Local Representation and Authorized Person

• If the manufacturer is located outside Hong Kong, they must maintain a local authorized representative or importer who will be responsible for ensuring compliance with regulatory requirements on their behalf.
• This representative will play a critical role in liaising with the Hong Kong Department of Health and handling any regulatory issues that may arise.

11. Stay Informed of Regulatory Changes

• Regulatory requirements may change over time, and manufacturers should stay informed of any updates to the MDACS, as well as international standards and guidelines, that could affect their device’s compliance.
• Regularly review official publications from the Hong Kong Department of Health for any new regulations or guidelines that may impact the device.

Conclusion

After obtaining Class I IVD medical device registration under Hong Kong MDACS, manufacturers and distributors must ensure continued compliance with regulatory requirements through effective post-market surveillance, quality management, and reporting of adverse events. Regular updates, timely renewal, and maintenance of device records are crucial for ensuring ongoing market access and safety. Additionally, being prepared for possible recalls, changes to the device, and staying informed about evolving regulations will help maintain compliance and avoid regulatory issues.