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    Home > Medical News > Latest Medical News > A number of medical device products are exempt from clinical trials, helping companies to reduce the burden of moving forward.

    A number of medical device products are exempt from clinical trials, helping companies to reduce the burden of moving forward.

    • Last Update: 2020-08-04
    • Source: Internet
    • Author: User
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    The Pharmaceutical Network Industry Dynamics, the State Drug Administration Medical Device Technology Review Center recently issued a notice on soliciting the opinions of the "New and Revised Medical Devices From Clinical Trials in 2020" (Draft for Comments), with the aim of further regulating the clinical evaluation of medical devices and expanding the scope of the list of medical devices exempt from clinical trials.
    from the contentofer, the revised medical device products a total of 13 items, including 9 categories of second-class medical device products, 2 three types of medical device products. Most of the revised product content
    revolves around product description and classification coding.
    at the same time, 53 new medical device products and 15 in vitro diagnostic reagents were added on the basis of the release of the 2019 supplemental "Exemption Catalog".
    in 15 in vitro diagnostic reagents, enzyme testing reagents accounted for 7, allergen detection reagents, protein testing, hormone testing reagents each accounted for 2, antibody testing reagents accounted for 1.
    it is understood that since September 2018, when the State Drug Administration issued the Notice on the Publication of the New Amendment to avoid clinical trials, a total of 1055 medical device products have been exempted so far, and 431 in vitro diagnostic reagents have been made, for a total of 1486.
    with the release of the 2020 edition of the "exemption catalog", further expand the scope of medical device scant from clinical trials, help to reduce the burden of related enterprises, so that enterprises can put more energy into product development and quality improvement.
    also helps more safe, effective and risk-controlled products to accelerate the market and international integration, in the case of meeting the domestic market, accelerate the pace of import substitution.
    ", "This new entry into the exemption catalog of in vitro diagnostic reagents products have 15, for the relevant in vitro diagnostic reagents enterprises is a big advantage, on the one hand, reduced the time and cost of the relevant reagents test.
    on the other hand, this part of the savings can be placed on product development.
    " is said by industry insiders.
    the first half of this year, test kits-driven domestic IVD market performance growth is significant.
    According to The Company's earnings in the first half of 2020, the company earned 620-800 million, up 924.57-1222.03% Year-on-Year, according to the results revision announcement.
    , mainly due to the test kit and nucleic acid testing instruments and related supplies of a large demand.
    Wanfu Bio's first-half earnings forecast showed a profit of 413-454 million, up 100-120% year-on-year.
    it is understood that Wanfu Bio's new crown colloidal gold products in addition to the domestic market, but also exported to Europe, Asia, Latin America and other more than 70 countries and regions.
    Huada Gene's first-half 2020 earnings forecast showed that its profit was 1.53-1.63 billion, up 672.83-723.35 percent year-on-year, mainly due to testing reagents.
    with the increasing demand for people's health, the risk prediction of disease, health management, slow disease management, etc. have higher requirements, as an important means of disease diagnosis in vitro diagnosis has been more and more people's attention.
    According to estimates by the Institute of Medical Equipment, the size of China's in vitro diagnostic market in 2018 will be about 60.4 billion yuan, up 18.43 percent year-on-year.
    industry generally believethat that the domestic high-tech medical equipment and even reagent supplies market prospects are considerable, and high-end equipment domestic substitution still has a lot of room, the market capacity is very large.
    " in the high-end sector, many products have not been domesticated.
    especially in the field of IVD, it is important to form closed loops from instruments to reagent supplies.
    in china involved in high-end IVD instruments are very scarce, because its technical barriers are relatively high, many products have not yet achieved full localization.
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