Implementation of the Principles for Determining Medical Device Classification

2023/8/11 17:09:19

(1) Classification of medical devices is carried out in accordance with the classification table.

(2) The classification of medical devices is determined primarily on the basis of their intended use and effect.

(3) The classification of the same commodity should be determined separately if the intention of use and the method of effect are different.

(4) The classification of accessories of medical devices should be separated from their supporting hosts and classified separately according to the status of the accessories.

(5) If a medical device can be applied to two classifications, the higher classification should be adopted. 

(6) Software that controls the functioning of a medical device is classified in the same category as the medical device.

(7) Merchandise that monitors or affects the primary function of a medical device is classified in common with the classification of the monitored and affected device.

(8)The State Drug Administration may adjust the classification of medical devices that require special supervision and administration according to the needs of work. 

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