Apply for a medical device license to have the following conditions: (a) with the scale and scope of operation of quality management institutions or full-time quality management personnel. Quality management personnel should have a state-recognized relevant professional qualifications or titles; (Now some places require quality management is a bachelor's degree, preferably in clinical medicine, the provincial bureau of materials after passing the municipal bureau will arrange an examination to quality management and legal persons to test) (b) with the scale and scope of operation of the relatively independent premises; (c) with the scale and scope of operation of the storage conditions. (C) with the scale and scope of operation of the appropriate storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical equipment products; (D) should establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking and reporting of adverse events system; (E) should have its operation of medical equipment products compatible with the technical training and after-sales service capabilities, or agreed to by the third party to provide technical support; (F) should have a medical device products to provide technical training and after-sales service capacity, or agreed to by the (vi) the specific conditions can be compared with the "Henan Province, medical device business enterprises on-site inspection and acceptance standards" "Henan Province, corneal contact lenses and care fluid business inspection and acceptance standards". (vii) Companies operating sterile and implantable products are required to establish a computerized management system and a computerized management system that can ensure effective quality tracking and tracing of products throughout the process from purchase to sale. Regarding the warehouse and and business premises: The company shall have a relatively independent business premises that is compatible with the scale of operation and business scope. Provincial municipalities within the area of the operation of integrated medical device enterprises with a floor area of not less than 180 square meters, professional agent enterprises with a floor area of not less than 120 square meters (the operating area of the headquarters of the retail chain of pharmaceuticals with reference to this standard, and should be set up separately in the office area of medical equipment). County-level cities (including counties) below the operation of integrated medical equipment business premises floor space of not less than 150 square meters, professional agent enterprise business premises floor space of not less than 100 square meters. Single-species agent enterprise business premises floor space of not less than 60 square meters. The business premises of the enterprise shall not be set up in residential type houses or residential areas. Enterprises shall have storage conditions appropriate to the scale and scope of business, including storage facilities and equipment that meet the requirements of the characteristics of medical device products. Enterprises that also operate medical device products shall have independent warehouse premises. Provincial municipalities operating comprehensive medical equipment warehouse floor area of not less than 150 square meters, professional agents warehouse floor area (drug retail chain headquarters part-time non-disposable sterile medical devices dedicated warehouse floor area) of not less than 60 square meters; county-level cities (including counties) below the operating comprehensive medical equipment warehouse floor area of not less than 100 square meters, professional agents of the enterprise warehouse floor area of not less than 60 square meters. Not less than 60 square meters. Single-species agent enterprises warehouse floor area of not less than 40 square meters. Operating single-use sterile medical devices (Class III injection and puncture instruments, single-use transfusion apparatus and tubing) products of the enterprise, the warehouse floor space of not less than 200 square meters; which the implementation of unified distribution, part-time or monopoly of the retail stores, specializing in medical equipment, software or medical magnetic **** vibration, CT, medical nuclide equipment, etc., may not be set up in the enterprise warehouse. Enterprise warehouse premises shall not be set up in residential type of housing or residential areas. On the business scope of enterprise personnel instructions: (a) according to the reporting enterprise to apply for the operation of the product categories, will apply for the enterprise is divided into five categories: comprehensive, professional agents, single-variety agent, testing and dispensing and pharmaceutical concurrently. Comprehensive category refers to enterprises applying to operate the second and third categories and with categories exceeding 10 major categories (including 10 categories) or more. Professional agent refers to enterprises applying for the operation of 2 to 10 categories of products; single-variety agent refers to enterprises applying for the operation of a major class of medical devices (except for implantable, interventional and artificial organ products, which are subject to the relevant standards of the professional agent category) series of products; dispensing category: refers to enterprises applying for the operation of corneal contact lenses and care solutions, hearing aids. Specialized refers to the operation of medical devices for all business enterprises; part-time refers to the operation of medical devices for non-all business enterprises.
(ii) According to the State Drug Administration in 2002 issued the "Medical Device Classification Catalog", for the convenience of supervision and management, medical device products are divided into the following categories.1, device category: 6801, 6802, 6803, 6804, 6805, 6806, 6807, 6808, 6809, 6810, 6812, 6813, 6816, 6820, 6827; 2, equipment and apparatus: 6821 (Class II), 6822 (Class II) 6823, 6824, 6825, 6826, 6831, 6834, 6840, 6841, 6845, 6854, 6855, 6856, 6857, 6858; 3, large-scale medical equipment: 6824, 6825, 6828, 6830, 6832, 6833; 4, implantation, intervention and artificial organs: 6821 (Class III), 6822 (Class III) 6846 (except for hearing aids), 6877; 5, medical materials: 6863, 6864, 6865, 6866 (except for 6866-1); 6, disposable sterile category: 6815, 6866; 7, software category 6870; 8, fitting category: corneal contact lenses, hearing aids; which operates in vitro diagnostic reagents and the State Drug Administration otherwise provided for the medical device products from its provisions. (C) the relevant professional means engaged in the business of medical devices and varieties of related professions. Standards specifically refers to the person in charge of quality management organizations and full-time quality management and quality acceptance of personnel, should have its business product categories related (medical devices, machinery and electronics, instrumentation, biology, physics, chemistry, medicine, pharmacy, chemical engineering, computers, medical engineering, numerical control, information automation, etc.) of the science and engineering professional qualifications