1, you said the registered capital we are not required, but for the business license must have the name approval notice of the Industrial and Commercial Bureau, or have the original enterprise business license.
2, on the enterprise legal person (responsible person) there is no hard and fast rules, only requires familiarity with the relevant national supervision and management of medical devices rules and regulations and have the appropriate professional knowledge of the quality of the products operated by the enterprise is responsible for the leadership, and shall not be responsible for the quality of the quality management organization or a full-time quality management personnel. Quality management personnel are required, as follows: operating a comprehensive or professional agent of large-scale medical equipment, medical materials, disposable sterile and implantable, interventional and artificial organ class medical device enterprises, quality management organization shall have a relevant professional nationally recognized undergraduate degree or above or intermediate or above technical title, and more than 3 years of experience in the quality of medical device business management. Professional agent of the second, third category of medical devices in the device class, equipment and apparatus class, software class, testing and fitting class of enterprises, quality management institutions or full-time quality management personnel should have relevant professional state-recognized college degree or above or junior or above technical title, and have more than 1 year engaged in the work of medical equipment practice experience. Operating a single category and part-time medical device retail pharmacy full-time quality management personnel should have a relevant professional state-recognized secondary school or above or by the drug full-time quality manager.
3, Class II and Class III medical device business enterprise license to the provincial drug supervision department. There should be a guide on the website of each provincial drug administration bureau