Hong Kong: Revision of Technical References “Artificial Intelligence Medical Devices” and “Personalised Medical Devices”, and Guidance Notes “Definitions and Abbreviations for MDACS”

October 28, 2025
Hong Kong, Regulatory Updates

On October 02, 2025, the Medical Device Division (MDD) of Hong Kong announced revisions to the following documents under the Medical Device Administrative Control System (MDACS):

Technical Reference “Artificial Intelligence Medical Devices (AI-MD)” (TR-008)
Technical Reference “Personalised Medical Devices” (TR-009)
Guidance Notes “Definitions and Abbreviations for MDACS” (GN-00)

All updates and corresponding Chinese versions took immediate effect.

Scope

Revisions of three MDACS reference documents — TR-008, TR-009, and GN-00 — with updates and issuance of Chinese versions.

Key Points

1. TR-008: Artificial Intelligence Medical Devices (AI-MD)

Section 4.4: Corrected a formatting error from the previous version.
Section 5.1: Updated the name of the Office of the Government Chief Information Officer (OGCIO) to the Digital Policy Office (DPO), reflecting the July 2024 merger with the Efficiency Office.
Chinese Version: Newly released with immediate effect.

2. TR-009: Personalised Medical Devices

Sections 3.2.4, and 4.2: Refined sentence phrasing for clarity.
Section 3.2.5: Removed the statement “It is typically not mass produced.” to prevent confusion.
Chinese Version: Newly released with immediate effect.

3. GN-00: Definitions and Abbreviations for MDACS

Section 2.42.3 (Chinese Version): Refined the sentence for improved clarity and accuracy.

References

You can access the documents here:

TR-008: Artificial Intelligence Medical Devices (AI-MD)
- Link to the updated English version
- Link to the new Chinese version

TR-009: Personalised Medical Devices
- Link to the updated English version
- Link to the new Chinese version

GN-00: Definitions and Abbreviations for MDACS
- Link to the updated Chinese version

Effective Date

Immediate effect

Implications to Client

There is no significant impact on current medical device registration or submission processes. However, clients should ensure that the latest versions of TR-008, TR-009, and GN-00 are referenced when preparing or updating technical documentation under MDACS.

Read the Announcement

Access the official announcements here:

Next Steps

If your organization is developing or registering AI-enabled or personalised medical devices in Hong Kong, our regulatory team can assist in interpreting the latest TR and GN requirements to ensure documentation compliance.