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Prosthetics And Orthotics (Assistive) Production Enterprise Qualification Procedures

Original Language Title: 假肢和矫形器(辅助器具)生产装配企业资格认定办法

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(October 12, 2005 the Ministry of Civil Affairs released 29th come into force on the date of promulgation) article under the State Council to set administrative administrative examination and approval items really necessary to be retained licensing decision (People's Republic of China promulgated by Decree No. 412) provides that these measures are formulated.
    Second this approach applies to assemble a prosthesis or orthosis (assistive) parts and directly by the enterprises for the disabled or patients with Assembly used for accreditation.
    Article prostheses and orthoses (assistive) catalogues, by the Civil Affairs Department under the State Council to the catalog of specialized supplies for amputees, China (hereinafter referred to as the catalogue) was published.
    Prosthetics and Orthotics in the directory (assistive) product manufacturing enterprises, in front of the industry and commerce registration shall be conducted by provinces, autonomous regions and municipalities directly under the people's Government departments of civil affairs qualification in accordance with the regulations. Fourth article application prosthetic and orthopaedic device (auxiliary apparatus) production Assembly enterprise qualification finds, should has following conditions: (a) by production Assembly of prosthetic and orthopaedic device (auxiliary apparatus) belongs to directory range within of products; (ii) has made prosthetic or orthopaedic device (auxiliary apparatus) making Division practice industry qualification certificate of professional technicians many Yu 1 people, made home industry unique jobs career qualification certificate of prosthetic assemblers or orthopaedic device assemblers many Yu 2 people; (three) has measurement take type, and gypsum processing, and
    Vacuum forming, grinding-decoration, bench Assembly, for line adjustment, thermoforming, prosthetic training and other special equipment and tools (four) with separate reception room, a prosthesis or orthosis (assistive) Studio and artificial limb training room, usable floor area of not less than 115 square meters. Fifth article application prosthetic and orthopaedic device (auxiliary apparatus) production Assembly enterprise qualification finds, should to province, and autonomous regions, and municipalities Government home sector submitted following material (a type two copies): (a) prosthetic or orthopaedic device (auxiliary apparatus) production Assembly enterprise qualification finds applications; (ii) made prosthetic or orthopaedic device (auxiliary apparatus) making Division practice industry qualification certificate of professional technicians of ID copies and making Division practice industry qualification certificate copies,
    Get the prosthesis fitters, orthotic fitters of professional qualification certificate (copy be checked with the original) and (iii) of this article fourth (c) provision of special equipment and tools list; (d) of this article fourth paragraph (d) provides proof of ownership and use of the site and a description.
    Sixth of provinces, autonomous regions and municipalities directly under the people's Government departments of civil affairs should be based on the People's Republic of China Law on administrative licensing provisions of 32nd and Enterprise qualification for applicants to apply for different situations to deal with.
    Article seventh province, autonomous region or municipality civil affairs departments in the process of review of application materials, and the need for special equipment and tools list, sites use of features such as verification, verification shall be assigned two or more staff. Eighth of provinces, autonomous regions and municipalities directly under the people's Governments of the Home Department shall accept the application within 20 working days of the decision whether or not to grant accreditation. Be found, issue a prosthetics and Orthotics (AIDS) certificate of qualification for production and Assembly enterprises.
    Not found, shall state the reasons in writing, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative suit.
    Nineth prostheses and orthoses (assistive) production and Assembly enterprises set up assembly operations branch, country appropriated funds, institutions, universities, social groups, such as the establishment of science and technology does not meet the corporate requirements of prosthetics and Orthotics (assistive) Assembly sector, in accordance with the provisions of these measures.
    Tenth article this way as of the date of promulgation.
                      Before the implementation of these measures has been registered with the industrial and commercial administration departments prostheses and orthoses (assistive) production and Assembly enterprises, since the implementation of this approach should be within 1 year, in accordance with the regulations, apply for business accreditation.