1, the opening of the second and third class of medical device business enterprises, should apply to the operating location of the Food and Drug Administration Branch and submit the following information:
( 1) "Medical Device Business License Application Form";
( 2) "Medical Device Business License Application Materials Registration Form";
( 3 ) business administration department issued by the enterprise name pre-approval documents or a copy of the "business license";
( 4 ) proposed enterprise quality management person in charge of the identity card, education or title certificate copy and personal resume;
( 5 ) proposed enterprise quality management personnel identity card, education or title certificate copy;
( 9 ) the proposed business scope of the enterprise, in accordance with the provisions of the Medical Device Classification Catalog of the management category, class code name to determine;
( 10 ) electronic filing materials.