1, the legal representative of the enterprise, the person in charge of the enterprise, quality management personnel should be no "supervision and management of medical devices regulations" Article 40 of the circumstances;
2, with the scale and scope of operation of the quality management institutions or full-time quality management personnel; quality management personnel should have a nationally recognized Relevant professional qualifications or titles, with qualified professional and technical personnel in accordance with the law. Such as quality management personnel should be on duty, shall not be part-time in other units
3, with the scale and scope of operation of relatively independent business premises.
4, with the scale and scope of operation of the storage conditions (storage equipment, facilities).
5, with the operating products for technical training, after-sales service capabilities.
6, should be in accordance with relevant national and local regulations, establish and improve the necessary quality management system, and strictly enforced.
7, 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.
8, in accordance with the "Guangdong Province to start the medical device business acceptance of the implementation of standards (revised in 2007)" acceptance.