Methods for Recognizing Qualifications of Enterprises Producing and Assembling Artificial Limb or Orthopedic Devices (Assistive Devices)

Methods for Recognizing Qualifications of Enterprises Producing and Assembling Artificial Limb or Orthopedic Devices (Assistive Devices)

Order of the Ministry of Civil Affairs No. 29

October 12, 2005

Article 1 These Measures are formulated in accordance with the provisions of the Decision of the State Council on Administrative Licensing for Matters Subject to Administrative Examination and Approval that Need to Be Maintained (Order of the State Council of the People's Republic of China No. 412).

Article 2 These Measures shall apply to the qualification accreditation of the enterprises that engage in the assembly of special components of prosthesis and orthosis (auxiliary apparatuses) directly for the use of the disabled or patients.

Article 3 The products contents of prosthesis and orthosis (auxiliary apparatuses) is promulgated in the form of the Contents of Special Articles for the Disabled Chinese (hereinafter referred to as "Contents") by the Ministry of Civil Affairs of the State Council.
The enterprises that engage in the production and assembly of prosthesis and orthosis (auxiliary apparatuses) listed in the Contents, shall, prior to the industrial and commercial registration, be subject to the qualification accreditation by the departments of civil affairs of the People's Governments of all the provinces, autonomous regions and municipalities directly under the Central Government in accordance with the provisions of these Measures.

Article 4 Enterprises applying for accreditation of the enterprise qualification for production and assembly of prosthesis and orthosis (auxiliary apparatuses) shall meet the following requirements:
1.
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