Wang Shucai, deputy director of the Medical Device Supervision Department of the State Food and Drug Administration, said that since the outbreak, the State Food and Drug Administration has established a list of export enterprises, further standardized export sales certificates, determined key inspection content, strengthened supervision and inspection, and focused on key export products. Strengthen the supervision and random inspection to ensure the safety, effectiveness and quality control of export products.
As of April 24, the local drug regulatory authorities sent a total of 10,307 inspection personnel to inspect 1,216 medical device manufacturing companies that have launched export operations and are ready to conduct export operations, with a total of 6,435 inspections and supervision and random inspection of 417 batches of products.
According to Wang Shucai, medical devices have played a very important role in the diagnosis, protection and treatment of new coronavirus. The drug regulatory department takes emergency examination and approval of new-type coronavirus detection reagents and other epidemic prevention and control urgently needed medical device products as an important task, and quickly starts the emergency approval process of medical devices. He took the new coronavirus nucleic acid detection reagent as an example, and carried out technical review, registration inspection, system verification and other tasks in parallel in accordance with the principles of “unified command, early intervention, follow-up review, and scientific approval” to maximize the review. Examination and approval efficiency, efficient service for epidemic prevention and control. Up to now, a total of 30 new coronavirus detection reagents have been approved, and the daily production capacity has reached 9.025 million.
It is understood that on the basis of the original query of relevant data, the State Food and Drug Administration specifically aggregates and summarizes the registration information of five categories of anti-epidemic medical devices such as new coronavirus detection reagents, medical protective clothing, medical masks, ventilators, and infrared thermometers, and carries out real-time dynamic Update, relevant information can be inquired in the column of the website of the State Food and Drug Administration.
Li Xingqian responded to the media report that “Chinese mask manufacturers have reduced prices and export masks have been sold at a low price” “China monopolized the personal protection market during the epidemic, and Chinese masks have been sold abroad at several times the price.” The price of export masks may fluctuate due to changes in supply and demand, and individual manufacturers may also have abnormal export prices, but overall, the price of Chinese export masks conforms to market principles and is a conscience quality. At the same time, the Chinese government has taken a series of measures to strengthen the quality supervision of epidemic prevention materials from production, trading, certification, export and other links Will be severely punished for actions that are indeed illegal and will never be tolerated.