The verification storm of the State Food and Drug Administration (hereinafter referred to as the Food and Drug Administration) began a whirlwind in the medical device industry . On September 7, the Food and Drug Administration issued an announcement on the official website, claiming that four clinical trials for medical device registration applications were suspected of producing false reports. At the same time, 51 companies withdrew their applications for 101 medical device registration projects. Wang Bo (pseudonym), a medical device industry official, told reporters that China's medical device companies are concentrated in the low-end competition, generally small in scale, low in technical content, and there are also data fraud in clinical trials. As regulators step up their efforts and tighten standards, more companies will retreat. In the view of Liu Daozhi, the founder of Shanlan Capital, this verification storm did not come suddenly. "It has always been, but it is wider and higher than the previous one." In January of this year, Bi Jingquan, director of the Food and Drug Administration, revealed at a meeting that there will be a lot of “new actions†in the supervision of medical devices this year. One of them is to clean up the data to create counterfeit rules and purify the research and development ecological environment. According to the announcement, Xiamen Bosheng Biotechnology Co., Ltd., Sichuan Mike Biotech Co., Ltd., Germany ORGENTEC Diagnostika GmbH and Korea Bioland Co. , Ltd. The clinical trial reports of the in vitro reagent products of the four companies are inconsistent with the actual situation, and will not be re-registered within one year from the date of non-registration. Among them, Mike Bio's Hepatitis B virus e antigen determination kit is in clinical trials. The clinical trial protocol stipulates that the test sample type is 350 serum, while the laboratory actual test sample type is plasma, and the sample type in the clinical trial report is serum. Mike Ting, a representative of Mike Bio Securities, explained in a telephone interview that from the inspection point of view, taking serum and plasma as samples does not affect the experimental results. However, due to the initial experimental protocol indicating that the sample type was serum, the company did not update the program in time, resulting in a violation of the clinical trial report. "This violation is not to say that the product has quality problems." Wang Ting further said that the product is a replacement product and will not affect the company's revenue. The Food and Drug Administration also announced on the same day that as of August 25, a total of 51 companies had withdrawn 101 medical device registration applications, including many famous companies such as Mindray, Haichang Contact Lenses and Minglang Bio. Liu Daozhi said that it usually takes one to three years for the medical device to be developed in the early stage, and it takes half a year to a year to apply for the registration certificate. With the strengthening of verification, the research and development costs of enterprises are too high and they are not willing to make fakes easily. In Wang Ting's view, the tightening of standards by the regulatory authorities is good for the industry, which can promote internal adjustments and constantly standardize and improve product quality. For decades, no core technology and high-end market has been the collective pain point of domestic medical device manufacturers. According to the China Medical Equipment Association, more than 70% of the market share of China's high-end medical equipment industry is dominated by three multinational companies such as General Electric (GE), Philips (Singapore) and Siemens (Siemens). Antibacterial,Dapoxetine Powder Active,Factory Supply Lapatinib,Top Quality Ezetimibe Benefit,Buy Cefuroxime Axetil, Antibacterial,Dapoxetine Powder Active,Factory Supply Lapatinib,Top Quality Ezetimibe Benefit,Buy Cefuroxime Axetil Xi'an Henrikang Biotech Co.,Ltd , https://www.henruikangbio.com.png)
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