On January 19th, the 2010 National Food and Drug Administration Work Conference officially came to an end. At the meeting, the State Food and Drug Administration clearly stated that this year China will focus on ensuring the quality and safety of essential drugs and improving the quality standards of 307 drugs that have previously entered the list of essential drugs. In the medical device industry , this year the state will increase the revision of basic and general-purpose medical device standards, and at the same time complete the revision of 89 medical device standards.
Guo Fanli, a researcher in the pharmaceutical industry of China Investment Consulting, pointed out that the country will revise the relevant standards of the medical device industry, which means that the medical device industry is about to enter the "high standard" era.
According to the CIC Consultant Industry Research Center, there are currently 180 national standards for medical devices in China, and there are more than 700 industry standards for medical devices. In 2009, China has newly established 24 national standards for medical devices, and newly introduced nearly 200 items in the industry standards, initially forming a medical device standard system with certain coverage.
Guo Fanli pointed out that the standards for these medical devices are far from enough. This "not enough" is manifested in two aspects. First, there is not enough "quantity". China's medical device industry standards are far from the standard and refinement of foreign standards, and there is a big gap in quantity compared with foreign countries; secondly, there is not enough "quality". Due to the non-standardization of medical device industry standards in China, there will be inconsistencies in local and local standards. In addition, compared with foreign medical device industry standards, China's standards are much lower than those of foreign countries. In other words, products that have passed the medical device industry standard in China may not pass the corresponding standards in foreign countries.
In response to this situation, China will further revise the standards for medical devices from this year. The revised focus includes in vitro diagnostic reagents, surgical implants, hemodialyzers, and more. At the same time, the State Food and Drug Administration will also strengthen the research work on medical device standards, improve the entry barriers of enterprises on the basis of the original medical device standard system, and organize basic research on standard verification, test methods and key indicators at all levels. .
According to the “2010-2015 China Medical Device Industry Investment Analysis and Prospect Forecast Report†issued by China Investment Consulting, there are more than 13,000 medical device manufacturers in China, but the problem of “scatter, chaos and bad†in the industry is still very high. serious. This time, the country will increase the revision of basic and general-purpose medical device standards to help improve the overall level of medical device enterprises, paving the way for the future of China's medical device industry to further the world.
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