1, "Medical Device License Application Form" (1 original);
2, "Business License" (copy);
3, Organization Code Certificate (copy);
4, legal representative, responsible person for business, quality responsible for the Proof of identity, education or title (a copy);
5, quality management personnel's work resume (1 original);
6, list of professional and technical personnel (1 original) and professional and technical personnel's identity cards, academic certificates, title certificates (a copy of each);
7, organization and departmental setup description;
8, the scope of business, business mode description;
9, business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or by the housing lease issued by the housing lease certificate copy. Warehousing commissioned by the third-party logistics of medical devices, provide a commissioning contract (a copy);
10, business facilities, equipment catalog.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 21
Registered Class II, Class III medical device products, its design, raw materials, production processes, scope of application, use of methods and other substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall be registered to the original registration authority Apply for a change in registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.