New medical device regulations will be regulated in three categories

Source: daily economic news 2014-12-05 medical device industry will meet new regulations Yesterday, the State Food and Drug Administration released a news, from yesterday, will open to the industry for "medical device classification rules (Draft)" The reporter learned from the draft that the new regulations will manage medical devices in three categories according to the degree of risk, from low to high The management categories of medical devices are divided into the first category (I), the second category (II) and the third category (III) Previously, in an interview with the reporter of the economic reference newspaper, the source disclosed that if the new regulation is successfully implemented, the CFDA will also issue regulations and normative documents of registration, production, operation, use and other relevant departments, covering all aspects of medical devices, so as to promote the structural adjustment and industrial upgrading of medical devices industry and enhance the quality and safety of medical devices in China Support capability According to Zhao Zhen, an analyst of Zhuo Chuang information pharmaceutical industry, the idea of "Classified Supervision" in the draft will have a certain impact on the future supervision of the medical device industry As far as the domestic industry is concerned, the implementation of classified supervision will make the industry standards clearer and more standardized, which is conducive to improving the overall concentration of the medical device industry "These impacts will surely gradually appear, because there are more domestic medical equipment enterprises than drug manufacturers, and it is estimated that there are about 15000 enterprises, large and small, with thousands of products." "At present, the output value of each domestic enterprise is within 10 million yuan on average If this draft can be implemented, the average output value of relevant enterprises will rise accordingly," he told the daily economic news Zhao town predicted that after the implementation of the new regulations, the leading position of the medical industry in Jiangsu, Zhejiang, Shanghai and Beijing Tianjin regions will be further strengthened, and good medical equipment resources will flow more to the above regions When it comes to the specification of medical devices, the regulatory authorities should take follow-up actions in the future, such as optimization, registration and supervision In the future, the demand for medical devices in grass-roots institutions in China will be greater, and the market potential in this respect will be relatively large Coupled with the regulatory spirit of the draft, it will be easier to promote the sinking of medical devices in China in the future, which will be beneficial to the development of practical and universal products, and the domestic medical devices will also get greater development space As for the impact on the imported device market, Zhao Zhen believes that if the draft can be successfully implemented, especially after the regulatory categories are clearly divided, the future device import will limit the indicators of many products and provide a good opportunity for the healthy and circular development of the domestic medical device market