On February 4, 2026, the Medical Device Division (MDD) of Hong Kong announced a revision to Technical Reference TR-008: Artificial Intelligence Medical Devices (AI-MD), with immediate effect from February 3, 2026. The revised version introduces more substantial updates compared to previous editions, strengthening technical, risk management, and labelling expectations for AI-enabled medical devices.
Scope
Revision of Technical Reference TR-008: Artificial Intelligence Medical Devices (AI-MD), introducing enhanced requirements relating to dataset management, model validation, operating system considerations, life cycle risk management, and AI-specific labelling for medical devices incorporating artificial intelligence or machine learning technologies. The revised requirements take immediate effect.
Background
TR-008 serves as the technical reference for the evaluation of artificial intelligence medical devices under Hong Kong’s Medical Device Administrative Control System (MDACS).
In the latest revision, MDD has introduced more detailed and explicit expectations to address emerging regulatory concerns related to data integrity, algorithm transparency, user over-reliance, and full life cycle risk management of AI-enabled medical devices.
Key Points
Enhanced Dataset and Model Validation
The revised TR-008 introduces stricter requirements on data handling, model development, and technical justification:
- Training, validation, and test datasets should not overlap. Any overlap or duplication must be fully justified by the manufacturer.
- Manufacturers must provide rationale for the appropriateness and adequacy of selected datasets and actively identify, manage, and address potential bias.
- A clear justification for model appropriateness is required, including explanations of model limitations and mitigating measures.
- Model evaluation must be conducted using a separate test dataset with defined evaluation metrics, and performance results must be provided.
Operating System and Device Limitations
Manufacturers are required to evaluate and clearly disclose limitations of both the AI medical device and its operating system (OS). These limitations must be communicated to users through device labelling to ensure safe and appropriate use.
Formal Risk Management Requirements (Clause 4.4)
A newly introduced Clause 4.4 mandates comprehensive life cycle risk management:
- Applicants must conduct risk management activities throughout the entire life cycle of the AI-MD in accordance with ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices) or an equivalent standard.
Specific AI Labelling Requirements (Clause 4.5)
Clause 4.5 introduces AI-specific labelling requirements to support safe and appropriate use, including:
- Intended user
- Warnings and precautions to prevent over-reliance on the AI-MD
- Description of the scope of AI application within the device
- Algorithm training summary
- Performance evaluation summary and clinical investigation summary, where applicable
Update to Reference Documents
The revised TR-008 cites an updated version of the Health Sciences Authority (HSA) guideline: Software Medical Devices – A Life Cycle Approach, Revision 3.0 (2024.03).
Implications to Clients
This revision reflects a clear regulatory shift toward increased technical transparency, accountability, and risk control for AI-enabled medical devices.
Manufacturers must ensure that dataset selection is justified, model performance is validated using separate test datasets, full life cycle risk management is implemented in line with ISO 14971, and comprehensive AI-specific information is provided in device labelling to mitigate user over-reliance.
Clients are strongly advised to review and update their quality management systems and technical documentation to align with the revised TR-008 requirements for all applicable AI-enabled medical devices.
Reference
You can view the full MDD announcement here: https://www.mdd.gov.hk/en/whats-new/mdacs-activities/index-id-2353.html
TR-008: Artificial Intelligence Medical Devices (AI-MD)
• Link to the updated English version
• Link to the new Chinese version
Next Steps
If you require assistance in interpreting the revised TR-008 requirements, updating technical documentation, or preparing MDACS submissions for AI-enabled medical devices, our regulatory team can support you throughout the process.
Contact us at info@nordpacificmed.com or click the button below for more details.