Medical device production license "is valid for five years, the license number, enterprise name, legal representative, responsible person, production address.
On this basis, to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure the safe and effective operation of medical devices.
For "large medical equipment configuration license" process in accordance with the principle of localized hierarchical management, apply for the configuration of Class B large medical equipment medical institutions should be through the local health administrative department of health level by level declaration to the municipal (state) health administrative departments.
1, application report. The main content includes: the basic situation of the applicant organization; to apply for the name of the equipment, specifications and main accessories; related auxiliary equipment name, number and use of personnel to obtain job training certificate;
2, feasibility study report, demand analysis. The main content includes: the main reasons for the application configuration; the application of the equipment technology development prospects; the role of clinical and scientific research; expected utilization; personnel to obtain post qualification; acquisition of funding sources and economic analysis.
Legal basis:
"Shandong Province, Class B large-scale medical equipment configuration license management implementation rules" Article B large-scale medical equipment configuration license shall follow the law, open and transparent, clean and efficient principle, promote the approval of service concepts, systems, styles of all-round deep change, and constantly optimize the service process, simplify the approval process, compression of the time limit for approval, and strive to create a "wide access, fast handling," and "the". "Wide, fast, strict control, convenient, open" approval service model.