Remarks:

1. Local Responsible Person (LRP) may apply their general medical devices under risk class II/III/IV and in vitro diagnostic medical devices under risk class B/C/D for listing under the Medical Device Administrative Control System (MDACS). For details on application for listing, please refer to Medical Device Listing Application.
2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer. The above examples of medical devices are for reference only. Please refer to "Classification of General Medical Devices" (Technical Reference TR-003) and "Classification of In Vitro Diagnostic Medical Devices" (Technical Reference TR-006) for details.
3. Where a medical device has features that place it into more than one class, classification should be based on the highest class indicated.
4. If there is any inconsistency or ambiguity between the English version and the Chinese version, the English version shall prevail.