备注：

1. Local Responsible Person (本地负责人) 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 "类别ification of General Medical Devices" (Technical Reference TR-003) and "类别ification of 体外诊断医疗器械s" (Technical Reference TR-006) for details.
3. 若某项医疗器械具有超过一个级别的特征，便应根据所符合的最高级别进行分级。
4. 如中、英文两个版本有任何抵触或不相符之处，应以英文版本为准。