After applying for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), manufacturers and distributors must adhere to specific rules and requirements to ensure continued compliance with local regulations. These obligations help maintain the device’s registration status and ensure it remains safe and effective for use in the market.

Key Rules and Requirements to Follow After Applying for Class I IVD Registration:

1. Post-Market Surveillance and Reporting

• Ongoing Monitoring: Once the device is registered and available on the market, manufacturers must continue monitoring the safety and performance of the device through post-market surveillance.
• Adverse Event Reporting: If any serious incidents or adverse events (e.g., device malfunction, patient harm) occur, the manufacturer must:
  • Report these incidents to the Hong Kong Department of Health.
  • In the case of serious incidents, reports must be submitted within 15 days from the manufacturer’s awareness of the event.
• Product Recall: If a defect or safety issue is identified, manufacturers must initiate a product recall and promptly notify the authorities. The recall process must comply with regulatory guidelines.
• Continuous Risk Assessment: The manufacturer must regularly update the risk management processes and ensure that the device remains safe for its intended use.

2. Annual Renewal of Registration

• Renewal Requirement: After the initial registration, manufacturers must renew their Class I IVD device registration with the Hong Kong Department of Health.
  • Renewal Frequency: The registration is generally valid for 5 years, after which the renewal process must be initiated.
  • Submission for Renewal: The renewal process may include submitting updated information about the device, confirming that the device still complies with all relevant standards, and verifying the continued validity of performance data.

3. Changes to the Device or Manufacturing Process

• Notification of Changes: Any significant changes to the device’s design, manufacturing process, intended use, or labeling must be reported to the Hong Kong Department of Health. This could include:
  • Design changes (e.g., new materials, components).
  • Changes in performance characteristics.
  • Alterations to intended use (e.g., expanding the device’s application or indication).
• Re-Assessment: Depending on the nature of the changes, the device may require a re-assessment by the authorities, which could involve submitting new documentation or data.

4. Quality Management System (QMS) Maintenance

• Ongoing Compliance with QMS: Manufacturers must maintain and adhere to an effective quality management system (QMS), especially if the device is manufactured in-house or abroad.
• Regular Audits: Conduct regular internal audits and quality control checks to ensure that the device continues to meet ISO 13485 (if applicable) or other relevant QMS standards.
• Corrective and Preventive Actions (CAPA): The manufacturer must implement corrective actions for any identified non-compliance or performance issues. This includes investigating the root causes and preventing future occurrences.

5. Labeling and Packaging Compliance

• Consistent Labeling: Ensure that the labeling and packaging of the device remain consistent with the registered information, including the instructions for use (IFU), warnings, and product specifications.
• Updates to Labeling: If there are any changes to the device (e.g., new indications or usage instructions), the labeling must be updated accordingly. All claims about the device’s performance must be substantiated by data.

6. Monitor Distribution Channels

• Authorized Representatives and Distributors: Ensure that any distributors or authorized representatives in Hong Kong are compliant with MDACS regulations.
• Importation and Sales Compliance: If the device is imported into Hong Kong, the manufacturer or authorized representative must ensure that the device is only distributed through authorized channels and complies with the importation procedures.

7. Document Retention and Record Keeping

• Retention of Records: Manufacturers must keep thorough records of all device-related documentation, including:
  • Design and production records.
  • Quality management system documentation.
  • Performance and safety data.
  • Post-market surveillance data.
• These records must be kept for a period of 5 years after the device is no longer marketed, ensuring that they can be accessed in case of audits or inspections by regulatory authorities.

8. Conduct Post-Market Clinical Follow-up (If Required)

• If clinical data is required to support the continued use of the IVD device, the manufacturer must monitor clinical performance and ensure ongoing clinical follow-up.
• This may involve additional clinical trials or studies to assess the long-term performance of the device.

9. Advertising and Promotion

• Marketing and Claims: Any advertising or promotional material related to the device must align with the registered intended use. Ensure that the device is not promoted for uses that are not approved or are unsupported by evidence.
• Compliance with Advertising Guidelines: Ensure that all marketing materials comply with local advertising regulations and do not make misleading or unsubstantiated claims about the device’s performance.

10. Inspections by Regulatory Authorities

• Inspections: The Hong Kong Department of Health may conduct inspections of the manufacturer’s facilities, distributors, or authorized representatives to ensure compliance with regulatory requirements.
• Ensure that all required records and documentation are accessible and up-to-date in case of an inspection.

11. Stay Updated on Regulatory Changes

• Regulatory Updates: Stay informed of any updates to the MDACS or other relevant Hong Kong regulations to ensure that the device remains compliant with any new requirements. Regulatory changes may include new standards, fees, or processes for device registration.
• International Standards Updates: Keep up with changes to international standards (e.g., ISO 13485, ISO 14971) that may impact the device’s compliance or safety requirements.

Conclusion:

After applying for and obtaining Class I IVD medical device registration under Hong Kong MDACS, manufacturers and distributors must follow several ongoing requirements to maintain compliance and ensure the device remains safe and effective. These include regular post-market surveillance, reporting of adverse events, changes to the device, and ensuring continued compliance with quality management systems. Proper documentation, adherence to labeling and packaging rules, and ensuring safe distribution channels are also critical components. By diligently following these requirements, manufacturers can ensure that their device remains in good standing within the Hong Kong market.