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In the fight against the epidemic, SAMR is taking action | Henan Provincial Drug Administration ensures the supply and quality of epidemic prevention drugs and medical devices
Category:
Industry News
Time：2020-02-17
Recently, the Henan Provincial Drug Supervision and Administration Bureau established an inspection and guidance team led by relevant responsible persons, consisting of staff from the Administrative Licensing Department, Medical Device Registration Department of the Provincial Drug Administration Bureau, and the Provincial Food and Drug Review and Inspection Center, to carry out solid work in the approval and guidance of medical devices for epidemic prevention and control.
On February 7, the inspection and guidance team rushed to Yanshi City, Luoyang City overnight to conduct on-site guidance on the preparations for the production of medical masks planned by Henan Silk Treasure Hygiene Products Co., Ltd.; on February 10, they went to Shangqiu Huamei Medical Technology Co., Ltd. for guidance. The inspection and guidance team evaluated the company's existing production conditions, production equipment, and testing capabilities, and put forward specific guidance opinions based on regulatory requirements. It is suggested that enterprises, on the one hand, can use mask machines and other production equipment in accordance with the product standard for respiratory protective equipment (GB2626-2006) to quickly form production capacity and supply the civilian market; on the other hand, they should quickly improve the production and testing conditions of medical devices, formulate product standards, and simultaneously carry out product registration and production license application work. At present, the Provincial Drug Administration Bureau has opened a green channel for administrative approval of epidemic prevention and control products, implementing emergency registration and inspection and emergency approval systems. For those that meet the conditions, product registration certificates and production licenses will be issued simultaneously.
As of February 9, the Henan Provincial Drug Administration Bureau has accepted a total of 252 batches of emergency inspections from 63 medical device manufacturing enterprises (units), including 229 batches of entrusted inspections, 2 batches of registration inspections, 2 batches of supervision inspections, and 19 batches of risk monitoring (1 batch unverified). The emergency inspections involved 7 categories of products, including disposable medical masks, medical surgical masks, medical protective masks, disposable medical protective clothing (kits), protective clothing raw materials, ethylene oxide sterilizers, and infrared thermometers.
In addition, in accordance with the unified deployment of the National Medical Products Administration, the Henan Provincial Drug Administration Bureau issued the "Notice on Severely Cracking Down on the Illegal Acts of Producing and Selling Counterfeit and Substandard Drugs and Medical Devices and Effectively Ensuring the Safety of Drugs and Medical Devices for the Prevention and Control of Novel Coronavirus Pneumonia Infection," requiring all levels of drug regulatory departments in the province to implement the "four strictest" requirements. For drugs among the key materials for epidemic prevention and control stipulated by the State Council, drugs in the diagnosis and treatment plan for COVID-19, and other drugs related to epidemic prevention and control, medical protective clothing, medical masks, related diagnostic reagents, ventilators and other medical devices, increase the intensity of supervision and inspection, further strengthen inter-departmental coordination and regional cooperation, and jointly crack down on illegal and criminal activities in the field of drugs and medical devices in accordance with the law, effectively building a solid defense line for epidemic prevention and control in Henan Province.
Keywords:
Formal, Zhengzhou, medical devices, R&D, new factory area, company, production, high-end, ten thousand yuan, limited company
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