Ministry of the People's Republic of China and the people's government of the People's Republic of China
People's letter [2006] no. 201
The ministry of civil affairs has issued a notice concerning the implementation of the measures on the identification of qualifications of enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices) and the measures on the registration of the professional qualifications of manufacturers of prosthetics and orthotics (auxiliary devices).
Departments (bureaus) of civil affairs of provinces, autonomous regions and municipalities directly under the central government:
Artificial limbs and orthopaedic devices, as auxiliary devices directly used for the disabled, are directly related to the physical health and personal safety of the disabled. (equipment) in order to strengthen artificial limbs and brace assembly production enterprise qualification management, standardize the prosthetic and orthoses occupational behavior (equipment), on the basis of the state council to is really necessary to retain the administrative examination and approval of project setting administrative licensing decision "(decree of the state council of the People's Republic of China no. 412, hereinafter referred to as the" decision "), The ministry of civil affairs has formulated the measures for the determination of qualifications of enterprises engaged in the production and assembly of prosthetics and orthotics (auxiliary devices) (order no. 29 of the ministry of civil affairs) and the measures for the registration of the professional qualifications of prosthetics and orthotics (auxiliary devices) manufacturers (order no. 33 of the ministry of civil affairs) (hereinafter referred to as the two measures). To implement two measures; To strengthen administration and administration in accordance with law, the following is the notice on relevant matters:
1. Do a good job in law enforcement and publicity
In accordance with the provisions of the administrative license law of the People's Republic of China (hereinafter referred to as the "administrative license law"), after the state council establishes an administrative license by issuing a decision, it is necessary to formulate administrative regulations on the administration of the administrative license. The strict implementation of the two measures indicates that the qualification identification of prosthesis and orthopedic device production and assembly enterprises and the registration of the professional qualification of prosthesis and orthopedic device manufacturer have been incorporated into the legal track. This not only creates a legal environment for the healthy development of prosthesis and orthopedic device industry, but also lays a foundation for the state council to formulate administrative regulations. All localities should conscientiously do a good job in publicizing law enforcement of the decision and the two measures, make unified arrangements and reasonable arrangements for law enforcement, improve law enforcement procedures and systems, and timely report any problems arising from law enforcement to the ministry of civil affairs.
Define the basic work
(1) to determine the scope of qualification for the implementation of enterprises licensed to produce and assemble prosthetics and orthotics. (equipment) in accordance with the prosthesis and brace assembly production enterprise qualification measures for the second and third of the ordinance, the assembly belongs to the China disabled persons specialized catalogue of products (hereinafter referred to as the "directory") within the scope of the prosthetic limbs or orthoses (equipment) special products, and directly by the enterprise for the disabled or patients with assembly using enterprise, before the industrial and commercial registration formalities, the need for artificial limbs and brace assembly production enterprise qualification. Enterprises that assemble or sell only artificial limbs or special parts for orthopaedic devices (auxiliary devices) products without assembling and using services for disabled persons or patients shall not fall within the scope of the measures for determining the qualifications of enterprises producing and assembling artificial limbs and orthopaedic devices (auxiliary devices). Please refer to annex 1 for the catalogue of 2006. In the future, the contents of the catalogue will be adjusted according to the needs of the market and the disabled. The catalogue will be published every 1-3 years.
(2) to ensure the number of practicing technicians in enterprises engaged in the production and assembly of prosthetics and orthotics. Open both limbs and orthoses (equipment), production assembly of business enterprise, should have a combination of artificial limb, orthopaedic implement two kinds of production assembly equipment, hire a qualification for technical personnel shall at the same time, with two limbs and brace skills make teacher qualification certificate, or at the same time there is more than one prosthetic production division and production division more than a brace.
Establish and improve a procedural system for the implementation of administrative licensing. The application and acceptance procedures shall be implemented in strict accordance with the provisions of article 32 of the administrative license law. Permission shall be granted if the application materials are complete and conform to the statutory form; If the application materials are not complete or do not conform to the statutory forms, the applicant shall be informed to make corrections; Errors that can be corrected on the spot in the application materials shall be allowed to be corrected on the spot; If the application does not fall within the scope of administrative license, it shall not be accepted upon notification.
Improve the system of forms and documents for administrative licensing. The basic format of the form document is as shown in annex 2 and annex 3 hereto. Please gradually improve it based on the specific situation.
Iii. Specific requirements for training and examination of prosthetics and orthotics assemblers and registration of prosthetics and orthotics fabricators
(1) the general office of the ministry of labor and social security and the general office of the ministry of civil affairs issued a notice on the professional standards of 8 countries, including the printing and distribution of prosthetics and orthotics (no.8 [2006] issued by the department of labor and social security), which published the professional standards for prosthetics and orthotics assemblers. The training center of the ministry of civil affairs will organize training and issue certificates in the second half of this year.
(2) the qualification examination for orthopaedic device makers will be held in the second half of this year.
(3) the registration time of prosthesis makers and orthopedic device makers shall be separately notified by China association of prosthetics and orthotics. Then, apply for initial registration personnel should be submitted to the ministry of civil affairs to social welfare and social affairs department (equipment) to make the prosthesis and brace teacher qualification registration measures for the listed in article 6 of the various materials and proves that the social welfare and social affairs department entrusted by the ministry of civil affairs China association of prosthesis orthoses to audit, audit qualified registered by the ministry of civil affairs. The China association of prosthetics and orthotics will compile the registration information and publish it online (http://www.cpoa.org.cn). All localities shall put on record the registered prosthesis makers and orthopedic device makers.
Ministry of civil affairs of the People's Republic of China
July 13, 2006
Issued by the general office of the ministry of civil affairs on 13 July 2006