First, Personnel Requirements, the need for six medical device-related professionals, one of which is a clinical medicine, if it is containing diagnostic reagents need two inspectors, quality management personnel, one of which is a supervisor of the inspector or with, inspection-related professional, university degree and engaged in more than three years of inspection work experience, and shall not be part-time, acceptance and after-sales service personnel with, inspection of secondary school or junior inspector title. Part-time, acceptance and after-sales service personnel with, inspection of secondary school education, or more than junior inspector title, these personnel are in the inspection site need to appear, and carry the original ID card and the original academic certificate,
Second, Site Requirements, if we operate a common class III medical device products, his Business premises and warehouse to meet business needs can be, that we need to have a commercial office space, which has tables and chairs and benches, computers and printers, filing cabinets, landline phones and other office facilities, commercial warehouse has a shelf, mouse board system tray, pallet, etc., here ah divided into two cases, if it is the operation of implantation intervention products, then the business area is not less than six months, the business area is not less than six months, the business area is not less than six months. Strong> can not be less than sixty square meters , the warehouse is not less than thirty square meters , if the business scope contains in vitro diagnostic reagents , the area of business should be compatible with the scale of operation, and not less than one hundred square meters , the warehouse is not less than one hundred square meters, the warehouse is not less than one hundred square meters, the warehouse is not less than one hundred square meters. Strong>, the area of the warehouse is not less than sixty square meters, low-temperature refrigeration shall not be less than twenty cubic meters, this situation is generally used by third-party cold storage is more, self-built due to the cost of the reason is very little,