Enterprises should have with the scale of operation of the quality management organization or full-time quality management personnel. Part of the medical equipment business should be relatively independent of the organization (such as medical equipment business department, etc.), there are designated department head, full-time quality management personnel and quality acceptance personnel. Chain business headquarters should be set up quality management organization, appoint the person in charge of quality management organization, the branch should be clear that a quality management personnel.
Enterprise quality management personnel should have college degree or above in medical device related majors or intermediate title or above, familiar with medical device management regulations and technical standards of the products operated. He or she has certain practical experience and the ability to solve quality problems in the business process. Enterprises operating hearing aids should be equipped with at least one technician with primary hearing test professional qualifications. Enterprises operating household physical therapy and rehabilitation equipment, with experience places, shall be equipped with a college or above or intermediate title of medical professional and technical personnel.
Quality management personnel should be on duty, not in other enterprises part-time.