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    Home > Medical News > Latest Medical News > A large number of enterprises take the initiative to cancel the "Medical Device Registration Certificate"!

    A large number of enterprises take the initiative to cancel the "Medical Device Registration Certificate"!

    • Last Update: 2022-08-15
    • Source: Internet
    • Author: User
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    [Pharmaceutical Network Industry News] On August 2, the State Food and Drug Administration announced that in accordance with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices", according to the application of enterprises, the registration certificates of medical devices for 6 products are now cancell.
    Products whose registration certificates have been cancelled involve ventilators, anesthesia machines and other produc.
    Recently, in addition to the news announced at the national level, a large number of local companies have also issued announcements on the initiative to cancel the "Medical Device Registration Certificat.
    For example, on August 2, the Anhui Provincial Drug Administration's announcement on agreeing to voluntarily cancel the "Medical Device Registration Certificate" by Anhui Ward Corning New Materials .
    , L.
    showed that Anhui Ward Corning New Materials .
    , L.
    voluntarily proposed to the bureau to cancel the product Application for registration certifica.
    According to the "Regulations on the Supervision and Administration of Medical Devices", the two "Medical Device Registration Certificates" held by the company have been cancelled in accordance with the l.
    On August 1, the Guangdong Provincial Drug Administration's notice (issue 45) on the cancellation of the "Medical Device Registration Certificate" was releas.
    In accordance with the provisions of the "Medical Device Registration Management Measures", according to the application of enterprises, the bureau has cancelled 18 according to l.
    Medical device registration certifica.
    Products whose registration certificates have been cancelled involve disposable medical masks, testing kits, endoscope cleaning workstations,e.
    On August 1, the Jiangxi Provincial Drug Administration's announcement on the cancellation of medical device production licenses (.
    34, 2022) showed that according to relevant regulations, a group of companies' "Medical Device Production Enterprise Licenses" were cancell.
    Among them, 7 medical device products were voluntarily applied for cancellation, and 1 was revoked according to l.
    On July 28, the Jilin Provincial Drug Administration announced the cancellation of the "Medical Device Production License" (.

    6 of 2022), showing that the "Medical Device Production License" of Jilin Province Kangmin Medical Device .

    , L.

    was cancelled after the application of the enterpri.
    On July 25, the Shaanxi Provincial Drug Administration's announcement on the cancellation of the two medical device product registration certificates of Shaanxi Zhengsheng Kangyuan Biomedical .

    , L.

    showed that according to the application of the enterprise, the medical surgical masks and 2 product registration certificates for disposable medical mas.

    The medical device production license is a certificate that medical device manufacturers must ho.

    With the cancellation of the certificate, it means that the related products of these enterprises will no longer continue to operate and produ.

    Industry insiders have analyzed that behind a large number of companies voluntarily selling their licenses and leaving the market, on the one hand, it is mainly due to the implementation of medical policies such as the "Regulations on the Supervision and Administration of Medical Devices" and the centralized procurement of medical devices, which has prompted some changes in the domestic medical device market, including the entire indust.

    With stricter supervision, reduced corporate profit margins and more intense market competition, some companies with weak strength and unsuccessful transformation have opted to withdraw from the mark.

    On the other hand, judging from the reasons for cancellation announced in various places, there are also some companies that were eliminated due to illegal operatio.

    This is the result of increased market regulation and the gradual standardization of the industry, and it is also the inevitable survival of the fittest when the industry enters the stage of high-quality developme.

    Medical devices are related to people's health and life safe.

    Under the background of increasingly strict industry supervision, enterprises need to keep up with the requirements of policies and industries, and at the same time accelerate transformation and innovation in the fierce market competition, in order to better survive and thri.

    continue to devel.

    As of 2020, the size of China's medical device market is about 818 billion yuan, nearly four times the growth rate of global medical devic.

    In 2021, the total size of China's medical device market is close to one trillion yu.

    With the support of a series of policies and the accelerated pace of import substitution, the scale of this market will continue to expand, and medical device companies that the industry believes have innovative capabilities are expected to stand out on the tra.

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