Regarding the production and operation qualifications of prosthetic limb companies, these questions you should know
Q
Qualification of prosthetic manufacturing enterprises
Dear leaders, our company is preparing to carry out prosthetic production and sales business first. What qualifications should be met for consultation? What documents do I need to apply for? Related policies for online inquiries: Announcement [2017] No. 424, National Development and Reform Commission [2019] No. 6, and Ministry of Civil Affairs Announcement No. 456 all mention the abolition and decentralization of legal provisions. It can be understood that prosthetic manufacturing enterprises only need to obtain a business license and no longer require the practice certificate personnel, 115 square meters of area, and other content specified in the Ministry of Civil Affairs Order No. 29 of the People's Republic of China. Or is it required to meet the requirements but not be recognized. What are the specific requirements for strengthening the in-process and post event supervision of prosthetic and orthotic (assistive device) production and assembly enterprises mentioned in the Notice of the Ministry of Civil Affairs (Min Fa [2019] No. 93)? Thank you, leader
Hello, according to the requirements of the State Council, the administrative license for the qualification recognition of prosthetic and orthotic (assistive device) production and assembly enterprises implemented by provincial civil affairs departments has been cancelled, and the registration of prosthetic and orthotic enterprises does not need to apply for administrative licenses from civil affairs departments, nor does it need to be filed with civil affairs departments.. Enterprises only need to go to the market supervision department to handle the enterprise registration (or annual inspection) procedures in accordance with the relevant laws and regulations for enterprise registration, and obtain a business license to produce and operate prosthetic products. But if the production and operation of the enterprise involves medical devices, it should follow the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices to handle registration, and specific information can be consulted with the market supervision department. In addition, according to the "Notice of the Ministry of Civil Affairs on Strengthening the in-process and post supervision of prosthetic and orthotic (assistive device) production and assembly enterprises" (Min Fa [2019] No. 93), enterprises should truthfully submit annual work reports to the civil affairs department before March 31 each year.
Question:
Qualifications of appraisers for the evaluation and appraisal of prosthetics and orthotics
According to Article 2 and Article 8 of the Provisional Regulations on the Qualification System of prosthetics and orthotics makers, appraisers for the evaluation and appraisal of prosthetics and orthotics should hold a professional qualification certificate for prosthetics or orthotics makers. The prosthetic and orthotic evaluation and appraisal certificate is now made by an appraiser holding a professional qualification certificate for prosthetics and a professional qualification certificate for orthotics production, to determine whether it meets the requirements..
Hello: On July 20, 2015, the State Council issued the "Decision on Cancelling a Batch of Occupational Qualification Licenses and Certification Matters" (Guofa [2015] No. 41), officially canceling the occupational qualification licenses and certification matters for prosthetic and orthotic manufacturers that were implemented by the Ministry of Civil Affairs.. According to the spirit of this decision by the State Council, the "Registration Measures for the Qualification of Practitioners of prosthetics and orthotics (assistive devices)" issued by the Ministry of Civil Affairs in 2006 (Order No. 33 of the Ministry of Civil Affairs of the People's Republic of China) and the "Interim Provisions on the Qualification System of Practitioners of prosthetics and orthotics" issued by the former Ministry of Personnel and the Ministry of Civil Affairs in 1997 (Ren Fa [1997] No. 38) have lost their effectiveness and are no longer applicable.