The person in charge of quality is required to have college education or intermediate title or above, related to more than three years of relevant quality management experience; other personnel, although there is no clear educational requirements, but it is recommended that secondary school or high school education or above.
Related to include bioengineering, materials, machinery, instrumentation, electrical information, chemical and pharmaceutical, engineering mechanics, etc., according to the points are more detailed, such as biomedical engineering, medical devices, optical instruments, electronic information technology, automation control, molecular materials and engineering. Medicine-related such as: clinical medicine, dentistry, Chinese medicine, nursing, pharmacy and so on.
Specific materials required:
1, the application form for business records.
2, business license and organization code copy.
3, the legal person, the person in charge, the person in charge of quality of the ID card and a copy of the academic certificate.
4, the floor plan of the business premises and warehouses, as well as property certificates or housing rental contracts.
5, business premises, business scope of the description (product registration information).
6, business facilities and equipment catalog.
7, business quality management system, working procedure document catalog.
8, computer management system basic information and functional description.