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    Home > Active Ingredient News > Drugs Articles > FDA: the consistency of Chinese medical devices with international standards is more than 90%

    FDA: the consistency of Chinese medical devices with international standards is more than 90%

    • Last Update: 2019-01-15
    • Source: Internet
    • Author: User
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    Medical network January 15 January 14, from the official website of the State Food and drug administration, it was learned that the consistency between China's medical device standards and international standards reached more than 90%, the coverage and systematization of the standard system continued to strengthen, and the overall level of medical device standards continued to improve In 2018, 99 items of preparation and revision of medical device industry standards were selected, 104 items of medical device industry standards were reviewed and issued By the end of 2018, there were 1618 medical device standards in China, including 219 national standards and 1399 industry standards Medical device standard is a common technical specification for the development, production, operation, use, supervision and management of medical devices, and an important technical support for the supervision and industrial development of medical devices The State Food and drug administration mainly carries out work from four aspects, including: strengthening the construction of medical device standard system, accelerating the preparation and revision of medical device standard, improving the system and management of medical device Standard Committee, and improving the international discourse power of medical device standard According to data from China Construction Investment Research Report, the global medical device market in 2017 exceeded US $400 billion, with a year-on-year growth rate of about 5%, slightly higher than the growth rate of the global pharmaceutical industry In 2017, the scale of China's medical device market exceeded 400 billion yuan, with a growth rate of more than 20% in recent years, far higher than the global growth rate, and also higher than the growth rate of about 10% of China's drug market scale Southwest Securities believes that, from the perspective of growth rate, the growth rate of medical device related income is significantly higher than that of drugs, becoming the main increase of hospital income; considering the zero plus of drugs and the implementation of policies to limit the proportion of drugs, medical device related income will become the main profit point of the hospital According to CSCI, through continuous R & D investment and cross-border M & A, China's leading equipment company has accumulated some core technologies, thus realizing the self production of key components and winning the high recognition of end customers; capital accumulation has also helped enterprises achieve leapfrog development CSCI believes that the road of China's rise as a leading equipment company is about to open.
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