On May 09, 2025, the Medical Device Division (MDD) of Hong Kong issued Technical Reference “Personalised Medical Devices” (TR-009), which provides definitions, classification tools, and examples related to personalised medical devices. Concurrently, updates were made to:
- GN-00: Guidance Notes for Definitions and Abbreviations
- GN-01: Overview of the Medical Device Administrative Control System
Key Highlights of the Issuance
- TR-009 introduces a framework for identifying personalised medical devices, including:
- “Personalised medical device” is defined as a general term encompassing:
- Custom-made devices
- Patient-matched devices
- Adaptable devices
- Additional update to GN-01:
The Local Responsible Person (LRP) must retain supply records for:- The lifetime of the device as defined by the manufacturer, or
- Seven (7) years from the date of supply,
- whichever is longer.
References
These references should be reviewed to ensure compliance with the latest requirements under the Medical Device Administrative Control System (MDACS):
- TR-009: Personalised Medical Devices
- This reference provides definitions, classification tools, and examples to help identify and manage personalised medical devices, including custom-made, patient-matched, and adaptable devices.
- GN-00: Definitions and Abbreviations
- This reference provides updated definitions and standardised terminology used across MDACS documentation, supporting clarity and consistency.
- GN-01: Overview of the MDACS
- This reference outlines the structure and scope of MDACS, and now includes updated requirements for the retention of supply records by Local Responsible Persons (LRPs).
Implications to Clients
TR-009 should be considered in all future applications involving personalised medical devices.
Please ensure that supply records (including importer/distributor details, manufacturer, model, batch/serial numbers, and quantities) are:
- Traceable, and
- Retained for the required duration as stated above.
Effective Date: Immediate effectFor assistance, contact us at info@nordpacificmed.com or click the button below.
