The Type test Report presented by the medical devices quality test agency recognized by the State Drug Administration（Applied to the Products of Class II and Class III）

1)  About the Scope of Acceptance for Examination of the Examination Center

The test on placing the Products under the competent unit shall be determined in accordance with the “government certified Scope of Acceptance for Examination of the Examination Center”. The enterprise may at its option select one among the qualified examination centers. In case of any ambiguity on the catalog of the Scope of Acceptance for Examination of the Examination Center, a written report  shall be submitted to the office of acceptance, and the office will deliver the case to the competent department to designate one center for test.

2) Under the following Circumstances, no test is required：

(1) Among the laboratory equipment, the electrophoresis apparatus、centrifuge、Ultra Low temperature refrigerator，paraffin slicing machine，paraffin embedding machine, cell centrifuge smearing machine, and full automatic dying machine  no clinical trial reports and Product Type Test Reports issued by the medical devices quality test agency and recognized by the State Drug Administration are required to be provided .

(2) The Products of Class I in accordance with catalog of classification of the medical devices Products of China.