Two, the first class of medical devices product filing application materials:
(1) the first class of medical devices filing form
(2) safety risk analysis report
(3) the product technical requirements
(4) the product inspection report
(5) the clinical evaluation information
(6) the product specification and minimum Sample design of sales unit label
(7) Manufacturing information
(8) Supporting documents
(9) Declaration of Conformity
(10) Proof of authorization by the operator.