Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are classified as Class II medical devices. According to the "supervision and management of medical devices regulations" [2] Chapter IV, Article 30 provides: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of these regulations. Article 29 to engage in medical device business activities, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices appropriate quality management system and quality management organizations or personnel.