Recently, the State Food and Drug Administration Medical Device Technology Evaluation Center (CMDE) issued the article "Announcement on the Resignation of Partially Unrecognized Application Materials", saying that it will be issued before October 1, 2014. The returned product information will be cleaned up and summarized, and will be publicized from September 22 to October 23. After the announcement, the product information of the non-objection will be terminated.
According to an industry research report released on September 29, CMDE's retired medical device products included about 1,154 in the past decade from 2005 to 2014. This review product involves many imported and domestic companies, from GPS, Abbott, Roche, Olympus to Mindray, Lepu, and Minimally Invasive; the products reviewed are IVD kits, dentistry, orthopedics. Dozens of product types such as endoscopes. Among them, 964 varieties of international big-name enterprises in the first line accounted for 83.5% of the total number of retired trials; there were about 190 varieties of domestic medical equipment.
Refunded product statistics
1154 medical device products were retired in a centralized manner, which is unprecedented in the history of resignation. Why is there such a large-scale medical device product centralized review, what is the signal that it releases to the industry and the market? Guolian Securities gave an answer in its industry research report.
First of all, the historical high of 1154 medical equipment products has a record high pressure from CMDE's excessive work pressure. The "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval issued by the State Council" proposed to improve the efficiency of review and approval, and clearly stated that before the end of 2016, the registration of the backlog of registration applications was digested, and the goal of achieving approval according to regulations was achieved in 2018. . It can be said that the large-scale centralized retreat of medical devices and the large-scale retreat of previous drugs have, to a certain extent, responded to the spirit of the State Council document and improved the efficiency of review and approval.
Secondly, this time, the medical equipment products have been retired, and there is a clear trend toward centralized drug approval and centralized review. The centralized review will inevitably require the consistency of the review scale, which will inevitably lead to centralized review. CMDE has to deal with a large number of examination and approval work, and has to draw a consistent scale to focus on the review. This requires the enterprise itself to declare Materials and procedures should be self-examined in time. The centralized retreat of large-scale medical equipment products is undoubtedly a strict clarion call for the medical equipment review system. The next medical equipment review will be aligned with the drug approval and will become more stringent.
Third, the research report also pointed out that this large-scale review is also a consideration for CMDE for the standard review and approval environment. The consistency of the approval scale can avoid the influence of human factors and more reflect the rigor of the system. Although the current centralized review brings a short-term pain, it still has positive significance to the market and industry in the long run. While urging the company to strictly regulate itself and self-inspect itself, it also regulates the review and approval environment, so that the work is carried out in an orderly and efficient manner.
Overall, this large-scale medical device product review is a medical device under the pressure of massive workload and under the guidance of the “Recommended Drug and Medical Device Approval Review System†announced not long ago. The centralized review and release of the signal that the medical device review and approval will be aligned with the drug review and approval system. Although the centralized review has brought a short-term pain, with the gradual advancement of the system, an efficient operation of the examination and evaluation center will bring more positive effects to enterprises, industries and markets. Guolian Securities believes that the centralized examination and approval of medical devices has been quietly opened, and centralized examination and approval and retrial have also been honed. The storm of centralized approval in the medical device industry has begun.
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