Legal analysis: (a) with the scale and scope of operation of the quality management organization or college education above two quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
Legal basis: "The People's Republic of China *** and the State Administrative Licensing Law"
Article 11 The setting of administrative licensing shall follow the laws of economic and social development, and is conducive to giving full play to the enthusiasm and initiative of citizens, legal persons or other organizations, to safeguard the interests of the public *** and the social order, and to promote the coordinated development of the economy, society and ecological environment.
Article XII of the following matters can be set administrative licensing:
(1) directly related to national security, public **** security, economic macroeconomic regulation and control, ecological environmental protection, as well as directly related to the safety of personal health, life and property, and other specific activities, which need to be approved in accordance with the statutory conditions;
(2) the development and utilization of limited natural resources, public **** (b) The exploitation of limited natural resources, allocation of public resources, and market access in specific industries directly related to the interests of the public ****, matters requiring the granting of specific rights;
(c) The provision of public services and directly related to the interests of the public **** occupations, industries, need to determine the qualifications and qualifications with special credibility, special conditions, or special skills;
(d) The important activities that have a direct bearing on the security of the public, personal health, life and property safety. (D) directly related to public **** security, personal health, life and property safety of important equipment, facilities, products, goods, in accordance with technical standards, technical specifications, through inspection, testing, quarantine and other means of validation of matters;
(E) the establishment of enterprises or other organizations, the need to determine the subject matter of the qualification;
(F) laws and administrative regulations can be set up in accordance with the provisions of the administrative licensing of other matters.