The medical device three certificates refer to: medical device product registration certificate (including a class of production record certificate, two or three types of registration certificate), medical device production license and medical device business license (including two types of business record and three types of business license).
(1)The medical device product registration certificate refers to the process of systematically evaluating the safety and effectiveness of the medical devices to be marketed, sold and used in accordance with the statutory procedures to decide whether to agree to their sale and use. There is a medical device product registration certificate companies can apply for a medical device production license, only with the production and sales of the product qualification. Process, domestic medical devices a class of filing certificates in the location of the municipal Food and Drug Administration for the second class in the provincial bureau for the third class to the National Bureau for processing. Cycle, the domestic class I filing certificate in two weeks to two months to get the certificate, class II product registration certificate in 4-6 months to get the certificate, class III product registration certificate in 14-18 months under the certificate. Imported medical devices one, two or three categories are handled in the State Food and Drug Administration.
(2) Medical device production license is a medical device manufacturer must hold the documents, first on-site verification and then under the certificate, and ultimately issued by the provincial Drug Administration audit. Sales of products produced by their own registration certificate, as long as there is a production license can be mass produced and sold. Cycle, class II and class III medical device production license under the certificate cycle are about 2 months.
(3) medical device business license is a medical device business enterprises must have the documents, the first class of medical devices business enterprises only need to add the sales of products on the business license can be; start the second class of medical devices business enterprises, should be to the provinces, autonomous regions, municipalities directly under the central drug supervision and management department for the record, issued by the "medical device business record voucher"; to start the third class of medical devices business enterprises, should be by the provinces, autonomous regions, municipalities directly under the central drug supervision and management department for the record, issued by the "medical device business record voucher"; to start the third class of medical devices business enterprises. Should be reviewed and approved by the provincial, autonomous regions, municipalities directly under the Central Drug Administration, and issued a "medical device business license", and ultimately issued by the local municipal bureau. It should be noted that: two types of business filing certificate is issued before verification, three types of business license is just the opposite, the first verification and then licensing. Cycle, two or three types of filing together in two months under the license, a separate two types of roughly 1 month under the license, a separate three types of cycle in two months to complete.