Measures for the determination of qualifications of enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices), adopted at the fifth ministerial meeting on September 19, 2005, are hereby promulgated and shall come into force as of the date of promulgation.
Department: long learning for lee
On October 12, 2005
Measures for determining the qualifications of enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices)
Article 1 these measures are formulated in accordance with the provisions of the decision of the state council on the establishment of administrative licenses for items subject to administrative examination and approval that need to be retained (order no. 412 of the state council of the People's Republic of China).
Article 2 these measures are applicable to the qualification recognition of enterprises that assemble artificial limbs or special parts for orthopaedic devices (auxiliary devices) and assemble and use them directly for disabled persons or patients by the enterprises.
Article 3 the catalogue of prosthetics and orthotics (auxiliary devices) shall be published by the civil affairs department under the state council in the form of the catalogue of special articles for disabled persons in China (hereinafter referred to as the catalogue).
Enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices) mentioned in the catalogue shall, before their industrial and commercial registration, be recognized as qualified by the civil affairs departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government in accordance with the provisions of these measures.
Article 4 an applicant for the qualification recognition of an enterprise engaged in the production and assembly of artificial limbs and orthotics (auxiliary devices) shall meet the following requirements:
(1) the prostheses and orthotics (auxiliary devices) manufactured and assembled fall within the scope of the catalogue;
(2) there shall be no less than 1 professional technical personnel who have obtained the professional qualification certificate of a prosthesis or orthopedic device (auxiliary device) manufacturer, and no less than 2 prosthesis fitters or orthopedic device fitters who have obtained the professional qualification certificate of a special type of work in the civil affairs industry;
(3) it has special equipment and tools for measurement, gypsum processing, vacuum molding, grinding and modification, fitter assembly, alignment adjustment, thermoplastic molding, prosthesis function training and so on;
(4) it shall have an independent reception room, a production room for artificial limbs or orthotics (auxiliary devices) and a functional training room for artificial limbs with a usable area of not less than 115 square meters.
Article 5 to apply for the qualification recognition of enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices), the following materials (in duplicate) shall be submitted to the civil affairs departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government:
(1) application for qualification recognition of enterprises engaged in the production and assembly of prosthetics or orthotics (auxiliary devices);
(2) a copy of the id card of the professional and technical personnel who have obtained the professional qualification certificate of the prosthesis or orthopedic device (auxiliary device) manufacturer and a copy of the professional qualification certificate of the professional and technical personnel who have obtained the professional qualification certificate of the prosthesis or orthopedic device assembler;
(3) a list of special equipment and tools specified in item (3) of article 4 of these measures;
(4) the ownership and use certificate and functional description of the site as stipulated in item (4) of article 4 of these measures.
Article 6 the civil affairs departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall, in accordance with the provisions of article 32 of the administrative license law of the People's Republic of China, handle the applications for enterprise qualification recognition submitted by the applicants in different circumstances.
Article 7 when the civil affairs department of the people's government of a province, autonomous region or municipality directly under the central government considers it necessary to verify the list of special equipment and tools and the functions of the site during the examination of the application materials, it shall designate two or more staff members to carry out verification.
Article 8 the civil affairs departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall, within 20 working days after accepting the application, make a decision on whether to approve or disapprove the qualification recognition. In case of identification, a certificate of qualification for an enterprise engaged in the production and assembly of prosthetics and orthotics (auxiliary devices) shall be issued. In case of disapproval, the applicant shall state the reasons in writing and inform the applicant that he has the right to apply for administrative reconsideration or bring an administrative lawsuit.
Article 9 enterprises engaged in the production and assembly of artificial limbs and orthotics (auxiliary devices) shall set up branch offices with assembly tasks, and institutions of public institutions, colleges and universities, scientific and technological social organizations with funds approved by the state, etc. shall set up prosthetic limbs and orthotics (auxiliary devices) assembly departments that do not meet the requirements of enterprise legal persons.
Article 10 these measures shall come into force as of the date of promulgation.
Enterprises that have registered with the administrative departments for industry and commerce before the implementation of these measures for the production and assembly of prosthetics and orthotics (auxiliary devices) shall, within one year after the implementation of these measures, apply for the recognition of enterprise qualifications in accordance with the provisions of these measures.