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China Office | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/about-fda/office-global-operations/china-office
    The top three medical device imports from China are surgical drapes, non-absorbable gauze and surgical gowns. Drugs and medical devices are overseen by the …

FDA - SFDA China, Safety of Drugs and Medical Devices

    https://www.fda.gov/international-programs/cooperative-arrangements/fda-sfda-china-agreement-safety-drugs-and-medical-devices
    "SFDA Requirements" means any Chinese laws, regulations or other requirements, including any amendment adopted after the date of entry into force of this Agreement, …

China Office Sees Increase in Use of Misleading Medical …

    https://www.fda.gov/international-programs/global-perspective/china-office-sees-increase-use-misleading-medical-device-registration-certificates-points-way-cdrh
    The Office of Global Policy and Strategy’s China Office (CNO), working with the FDA’s Center for Devices and Radiological Health (CDRH), has identified companies …

National Medical Products Administration - NMPA

    http://english.nmpa.gov.cn/
    On the evening of December 20, 2022, the "China International Medical Device Regulatory Forum (CIMDR) - Global Harmonization Working Party (GHWP) Session & International …

Certain Respirators from China May Not Provide …

    https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter

    China Medical Device Registration - CFDA …

      https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/china/
      The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare …

    China Introduces New Medical Device Regulations - FDAnews

      https://www.fdanews.com/articles/202160-china-introduces-new-medical-device-regulations
      China Introduces New Medical Device Regulations April 5, 2021 The Chinese State Council has approved new medical device regulations that will go into effect on …

    An Overview of Medical Device Regulations …

      https://www.regdesk.co/an-overview-of-medical-device-regulations-in-china/
      An Overview of Medical Device Regulations in China. The National Medical Products Administration (NMPA), previously the China Food and Drug …

    Medical Devices | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/Medical-Devices
      Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research …

    Medical Device Databases | FDA

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
      Apr 6, 2022



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