1, the legal representative of the enterprise, the person in charge of the enterprise, the quality management personnel should be no "supervision and management of medical devices regulations" Article 40 of the situation.
2, the enterprise should have with the scale and scope of operation of the quality management organization or full-time quality management personnel.
3, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
4, should be in accordance with relevant national and local regulations, the establishment of a sound and necessary quality management system, and strictly enforced.
5, should collect and save the national standards for medical devices, industry standards and supervision and management of medical devices, rules and regulations and special provisions.