Hong Kong: Revision of Technical Reference “Software Medical Devices and Cybersecurity” (TR-007)

On May 13, 2025, the Medical Device Division (MDD) of Hong Kong announced the revision of Technical Reference “Software Medical Devices and Cybersecurity” (TR-007). Key updates include:

• New Section 4.1.5: Establishes a link to TR-008 (Artificial Intelligence Medical Devices), highlighting additional listing requirements for AI-based medical devices.
• Section 5.5.7: Updates the name of the Office of the Government Chief Information Officer (OGCIO) to the Digital Policy Office (DPO), reflecting the merger with the Efficiency Office in July 2024.
• Other changes: Formatting and language refinements throughout the document.

Key Highlights of the Issuance

• TR-007 provides guidance on the classification, listing, and cybersecurity requirements for Software as a Medical Device (SaMD) under the Medical Device Administrative Control System (MDACS).
• The revision strengthens the connection between TR-007 and TR-008, ensuring consistency in regulatory expectations for AI-enabled medical devices.

References

These references should be reviewed carefully to ensure full compliance with the latest regulatory expectations in Hong Kong:

• TR-007: Software Medical Devices and Cybersecurity
  • This reference provides guidance on the classification, listing, and cybersecurity requirements for Software as a Medical Device (SaMD).
    
• TR-008: Artificial Intelligence Medical Devices (AI-MD)
  • This reference provides additional requirements for AI-enabled medical devices to ensure regulatory alignment.
    

Implications to Clients

Ensure alignment between TR-007 and TR-008 when preparing submissions for software-based or AI-enabled medical devices.
Review the updated terminology and references to maintain compliance with the latest regulatory expectations.

Effective Date: Immediate effectFor assistance, contact us at info@nordpacificmed.com or click the button below.