Chongqing food and Drug Administration implemented the emergency approval procedure to promote the rapid bidding of "medical mask", "medical disposable protective clothing" and other four enterprises

Fighting against the novel coronavirus pneumonia, we must race against time The reporter learned from the Municipal Food and drug administration that in accordance with laws, regulations and relevant provisions, the Bureau implemented emergency approval procedures for medical devices in the special period of anti epidemic This is only to promote the rapid production of medical equipment enterprises and guarantee the supply of medical materials for epidemic prevention and control in our city Fighting against the novel coronavirus pneumonia, we must race against time The reporter learned from the Municipal Food and drug administration that in accordance with laws, regulations and relevant provisions, the Bureau implemented emergency approval procedures for medical devices in the special period of anti epidemic This is only to promote the rapid production of medical equipment enterprises and guarantee the supply of medical materials for epidemic prevention and control in our city According to the introduction of the relevant person in charge of SFDA, according to the idea of overall investigation, on-site inspection, expert evaluation, emergency approval, in plant supervision, assistance in inspection and quality assurance, the procedure speeds up the review and approval of enterprises applying for production of emergency medical devices, and helps enterprises that are temporarily unable to carry out the full project inspection to carry out 24-hour inspection, reduce and remit relevant entrusted inspection fees, etc Attentive service, to help promote the rapid production of enterprises It is understood that since the emergency quick review channel was opened, the SFDA has approved 7 products such as "medical masks" and "medical disposable protective clothing" declared by 4 enterprises The reporter learned from Chongqing Baina Medical Equipment Co., Ltd., located in Nan'an District, that since the resumption of production on January 22, the company has been continuously producing for 24 hours, with the cumulative production of more than 1.5 million medical masks Employees of Chongqing Baina Medical Equipment Co., Ltd are working hard on the production line According to Wang Haifeng, resident supervisor of SFDA, as the largest manufacturer of medical surgical masks and disposable medical masks in our city, the company stopped production at the end of October last year for various reasons In the face of the severe situation of epidemic prevention and control, the enterprise submitted a report on resuming production to the Municipal Drug Administration on January 21 "At the first time of receiving the application from the enterprise, SFDA started the emergency approval procedure, organized experts to work overtime for guidance, helped the enterprise standardize the quality control system, and passed the review within one day Such high efficiency has greatly improved our confidence " Cao Zhen, general manager of Chongqing Baina Medical Equipment Co., Ltd., told reporters that at the same time, the green emergency inspection channel opened by Chongqing medical equipment quality inspection center has left the enterprise with no worries, just full production and fast supply guarantee At present, there are 4 medical mask manufacturers in our city The relevant person in charge of SFDA said that the SFDA would continue to adopt emergency approval procedures for medical devices needed for epidemic prevention and control, strive for the relevant products to be listed as soon as possible, strengthen the supervision and inspection of emergency medical device manufacturers, and effectively guarantee the quality, safety and effectiveness of emergency medical devices (original title: SFDA implemented the emergency approval procedure and promoted the quick bidding of "medical mask", "medical disposable protective clothing" and other enterprises) penicillin source: Chongqing Business Daily