1, business license (business scope contains three types of in vitro diagnostic reagents sales range) rent contract, a copy of the title certificate. Personnel physical examination.
2, personnel requirements. At least four people, the person in charge of quality requires college education or intermediate title or above, relevant professional more than three years of relevant quality management experience,
3, site requirements. Cold storage of not less than 20 cubic meters. Housing lease agreement (lease period of more than one year) a copy of the real estate license. Office area is separated from the warehouse. Equipped with office facilities, equipped with five defense equipment and facilities. Warehouse requirements to do color-coded management.
4, software requirements. Must install and use the medical device GPS software.