Can Class II medical devices be clinical?

Need, but if how to stipulate can also not do. Measures for the Administration of Medical Device Registration, Article 22 The first class of medical devices for the record, without clinical trials. Application for registration of Class II and Class III medical devices, clinical trials should be conducted.

One of the following circumstances, can be exempted from clinical trials:

(A) the working mechanism is clear, the design is finalized, the production process is mature, has been listed in the clinical application of the same varieties of medical devices for many years and no record of serious adverse events, do not change the routine use;

(B) through the non-clinical evaluation can be proved to be safe and effective of the medical device;

(C) through the clinical trials of the same variety of medical devices or clinical use of the data obtained by analyzing and evaluating, can prove that the medical device is safe and effective.

Exempt from clinical trials of medical devices catalog by the State Food and Drug Administration to develop, adjust and publish. Not included in the directory of medical devices exempted from clinical trials, through the clinical trials of the same variety of medical devices or clinical use of data obtained by analyzing and evaluating, can prove that the medical device is safe and effective, the applicant can be declared for registration to explain, and submit relevant information.