Recently, the Henan Provincial Drug Administration established an inspection steering group led by relevant persons in charge, and composed of staff from the Provincial Drug Administration Administrative Licensing Office, the Device Registration Office, and the Provincial Food and Drug Evaluation and Inspection Center to carry out epidemic prevention and control medical devices. Approval and guidance work.

The inspection and guidance team rushed to Yanshi City, Luoyang City overnight on February 7 to provide on-site guidance on the preparations for Henan Silk Zhibao Sanitary Products Co., Ltd.'s planned production of medical masks; February 10, went to Shangqiu Huamei Medical Technology Company for guidance. The inspection and guidance team evaluates the existing production conditions, production equipment, and inspection capabilities of the enterprise, and provides specific guidance on the requirements of the standard regulations. It is recommended that on the one hand, companies can use mask machines and other production equipment in accordance with the respiratory protection product standard (GB2626-2006) to form production capacity as soon as possible to supply the civilian market; on the other hand, to improve the production and inspection conditions of medical devices as soon as possible, and formulate product standards , Carry out product registration and production license declaration simultaneously. At present, the Provincial Food and Drug Administration has opened a green channel for the administrative approval of epidemic prevention and control products, and implemented emergency registration inspection and emergency approval systems. For eligible products, product registration certificates and production licenses will be issued simultaneously.

As of February 9, the Henan Provincial Drug Administration has accepted a total of 252 batches of emergency inspections from 63 medical device manufacturers (units), including 229 batches of entrusted inspections, 2 batches of registered inspections, 2 batches of supervisory inspections, and 19 batches of risk monitoring (1 Batch not verified). The products involved in the emergency inspection include 7 categories of disposable medical masks, medical surgical masks, medical protective masks, medical disposable protective clothing (kits), protective clothing raw materials, ethylene oxide sterilizers, and infrared forehead thermometers.

In addition, the Henan Provincial Food and Drug Administration issued the "Notice on Severely Cracking Down on Illegal Activities in Manufacturing and Selling Fake and Inferior Medicines and Medical Devices to Effectively Guarantee the Safety of Drugs and Medical Devices for the Prevention and Control of the Novel Coronavirus Infection Pneumonia Epidemic" in accordance with the unified deployment of the State Food and Drug Administration. The provincial drug regulatory authorities at all levels implement the "four strictest" requirements for the drugs in the key epidemic prevention and control materials specified by the State Council, the drugs in the new coronary pneumonia diagnosis and treatment plan, and other drugs related to epidemic prevention and control, medical protective clothing, and medical masks , Relevant diagnostic reagents, ventilators and other medical equipment, intensify supervision and inspection, further strengthen departmental linkage and regional cooperation, and jointly crack down on illegal and criminal acts in the field of drugs and medical devices in accordance with the law, and effectively build a solid line of defense for epidemic prevention and control in Henan Province.