Provincial Drug Administration Strengthens Supervision of Enterprises Involving Epidemic Materials
Build a solid line of defense for the quality and safety of medical devices for epidemic prevention and control during the Spring Festival
Huasheng Online, January 14th (all media reporter Xiao Zuhua, correspondent Wang Qubo Quanrui) The relevant person in charge of the Provincial Drug Administration revealed today that the bureau has issued a document to pass the special supervision and inspection of epidemic prevention and control drug and medical device manufacturers, Unannounced inspections, on-site supervision, etc., built a solid line of defense for the quality and safety of medical devices for epidemic prevention and control during the Spring Festival, and promoted the implementation of the “New Year’s Guard” campaign to be effective.
The relevant person in charge of the bureau revealed that 15 manufacturers of new crown virus detection reagents, medical protective masks, ventilators, oximeters, oxygen concentrators and other products will be selected to implement key supervision and one-on-one service in the factory; Manufacturers of new crown virus detection reagents and medical protective masks carried out special supervision and inspection, and carried out unannounced inspections on 5 medical device manufacturers that failed many product sampling inspections, reported complaints, and had many supervision and inspection problems. At present, the province has organized 18 inspection teams, dispatched 135 inspectors, completed the inspection of 65 enterprises, investigated more than 120 potential risks, and ordered 5 enterprises to suspend production and rectify.
At the same time, the Provincial Drug Administration will also advance through the combination of investigation and investigation, focusing on whether the enterprise is producing without a license, whether it is producing in an unlicensed site, whether the quality management system is operating normally, whether the product quality is qualified, and whether the production site has been used for other purposes. Check with etc.
In the next stage, the Bureau will focus on hot consumption products and supply-demand contradictions after the adjustment of prevention and control policies, do a good job in the quality and safety of epidemic prevention and control drugs and medical devices and promote production and supply, and open a green channel for the application of administrative licenses for epidemic prevention drugs and devices. Under the premise of reducing the cost, the examination can be conducted as soon as it arrives, and the examination and approval can be carried out quickly.