Beijing, for medical equipment business license, for the number of quality management personnel, the specific requirements of education

For medical equipment companies first to determine the scope of your business, because the scope determines the ease of your said investment costs, especially the cost of medical equipment license, especially February 1, 2012 implementation of the application on the "medical equipment license site acceptance criteria," there are some great changes, because the scope of your business determines the scope of your office, warehouse, personnel, and so on the relevant requirements, office and warehouse must be independent and size requirements, personnel have professional requirements. And so on the relevant requirements, offices and warehouses must be independent and size requirements, personnel have professional requirements, here I simply do an answer to the above question, the number of regulations on quality management and educational requirements we can roughly interpreted in this way: In general, if your business scope of apparatus, equipment products, you need computer-related college degree or above and have a certain amount of experience in the work of the Specialized personnel, such as: computer management and application, computer software engineering, computer information technology, computer electronic engineering, etc.; if the scope of no apparatus, equipment, two or three types of devices, that is, medical-related professional college and have a certain amount of work experience in specialized personnel, such as: clinical medicine, nursing or advanced nursing, pharmacy, bioengineering, etc.; as for the number of personnel is stipulated in this way If the experience of a single class of products, then it can be 1 person, this person is both the person in charge of quality and inspector, if the operation is not a single class of products, then at least 2 people, a person in charge of quality (only 1), an inspector (can be more than one), remember: the person in charge of quality is very important, the person's name will be the same as the person in charge of the legal person or enterprise has to play to the "Medical Device License" on the The person in charge of quality is very important, this person's name will be the same as the legal person or the person in charge of the enterprise has to hit the "Medical Device License", his / her departure will have an impact on your business, so it must be the boss trusted people. As for the title of the analysis is simple, let's say: professional pharmacist, professional inspector, etc., title and academic specialty has nothing to do, the Drug Administration only measure your business has no relevant professional experienced personnel. (具体的看新法规或咨询583686395@qq.com), so the investment cost has increased greatly, I engaged in this work for many years, obviously feel that now do a "medical device business license" really suffering those who start a new business. Medical Device Business License" is a pre-approval item, if you do not approve in advance can also be, the first business license to do and then take. Medical Device Business License" to add items is the same, just a little trouble! Specific direct qq or e-mail advice!