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Common Websites for Medical Device Professionals

time：2026-06-17

Category: National Policies, Laws and Regulations

· National Health Commission (NHC)
  Offers policies, news and regulatory interpretations related to medical devices.

      http://www.nhc.gov.cn/wjw/gfxwjj/list_5.shtml

  · National Medical Products Administration – Medical Devices Section

    The Medical Devices Section of the National Medical Products Administration (NMPA) releases regulations, registration and          supervision information specifically for medical devices.

       https://www.nmpa.gov.cn/ylqx/index.html

  · National Medical Products Administration Advanced Training Institute

     It provides training and advanced courses related to medical devices, offering professional educational resources for                     practitioners.

        https://www.nmpaied.org.cn/

  · Bureau of Medical Administration

       Affiliated to the National Health Commission, this bureau oversees medical services and medical institutions, and issues                             regulations concerning the use of medical devices.

         http://www.nhc.gov.cn/yzygj/new_index.shtml

  · Center for Inspection and Evaluation, NMPA

     This institution is responsible for reviewing and inspecting medical device registration applications, and releases relevant               information on device evaluation.

        https://www.cfdi.org.cn/cfdi/index?module=A001&nty=A25

  · China Food and Drug News – Medical Devices Channel

    It delivers industry news, updates on laws and regulations for medical devices, and is ideal for enterprises to keep track of            industry trends.

      http://www.cnpharm.com/ylqx/

  · Center for Medical Device Evaluation, NMPA

    A national-level technical evaluation body for medical devices, responsible for the technical review and supervision of medical      devices.

       https://www.cmde.org.cn/index.html

  · Device Evaluation Cloud Classroom

     It offers online training courses on technical review of medical devices to help practitioners acquire relevant expertise.

       https://learn.cmde.org.cn/

 · Classification Catalogue & Guidelines
    It provides the medical device classification catalogue and relevant guidelines for reference by enterprises and practitioners.

        https://www.cmde.org.cn/flfg/zdyz/flmlbzh/flmlylqx/index.html

 · Medical Device Registration Inquiry
   An official database for practitioners to look up medical device registration information.

       https://www.nmpa.gov.cn/datasearch/ie-home-index.html#category=ylqx

   · Medical Device Adverse Event Inquiry

     An official platform for querying adverse events of medical devices, helping users understand product usage risks.

        https://www.cdr-adr.org.cn/ylqx_1/Medical_aqjs

   · NIFDC - Medical Device Standard Classification Inquiry

      It provides the inquiry function for medical device standard classification, helping practitioners learn about relevant device            standards.

        http://app.nifdc.org.cn/biaogzx

   · NIFDC - Standard Update Information

     It releases updates on medical device standards, helping practitioners keep abreast of the latest standard developments.

        https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/index.html

   · CNAS Accredited Laboratories & Qualification Inquiry

     It supports inquiries about accredited laboratories and relevant qualifications to ensure compliance of medical device testing.

        https://las.cnas.org.cn/LAS_FQ/publish/externalQueryL1.jsp


Commonly Used Websites for US Medical Devices

   · U.S. Food and Drug Administration (FDA)

   The FDA is the primary regulatory authority for medical devices in the United States, responsible for device approval and post-market           management.

       https://www.fda.gov/

   · Code of Federal Regulations (CFR)

      Query U.S. federal regulations related to medical devices and learn about compliance requirements for devices.

       https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl

   · U.S. Medical Device Database

     A database for searching medical devices marketed in the United States, providing product information and compliance status.

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

   · U.S. Unique Device Identification (UDI) System

     The Unique Device Identification System standardizes the tracking and management of medical devices.

       https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-                                system#ruleguidance

   · GUDID Database

      The U.S. Unique Device Identification database, used to query unique identification information of medical devices.

      https://accessgudid.nlm.nih.gov/

   · Medical Device Recall Database

      An official database for inquiries into U.S. medical device recall information, helping users check recall status.

       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

   · U.S. Medical Device Standards Database

      It provides access to medical device standard inquiries to ensure products comply with relevant U.S. standard requirements.

       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm/

   · FDA Guidance Document Inquiry

      It is used to search for FDA guidance documents related to medical devices and help enterprises comply with regulations.

       https://www.fda.gov/regulatory-information/search-fda-guidance-documents#guidancesearch

   · FDA Recognized Consensus Standards Inquiry

      It enables searches for consensus standards recognized by the FDA to ensure product standardization.

       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

   · FDA Forms Inquiry

       An official platform for searching commonly used FDA forms, facilitating the submission of medical device application documents.

       https://www.fda.gov/about-fda/reports-manuals-forms/forms

   · 510(k) Number Inquiry

    Look up 510(k) numbers of medical devices to check their approval status for the U.S. market.

       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

   · FDA Device Classification Inquiry

      Search FDA medical device classifications to help enterprises clarify the regulatory category of products.

       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm


Commonly Used Websites for EU Medical Devices

   · EU Medical Device Expert Committee

      The official website of the EU expert committee on medical devices, providing industry regulations and policy guidance.

       https://health.ec.europa.eu/index_en

   · EUDAMED

      The European Union medical device database, used to check the registration and compliance status of medical devices.

       https://ec.europa.eu/health/md_eudamed/overview_en

   · MDR Regulation

      The EU Medical Device Regulation (MDR) elaborates on compliance requirements for medical devices placed on the EU market.

       https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320

   · MDCG Guidance

      Guidelines issued by the EU Medical Device Coordination Group, helping enterprises understand relevant regulations and                          compliance requirements.

        https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

   · List of Notified Bodies for Medical Devices

     Directory of EU notified bodies for medical devices, assisting enterprises in finding certification bodies compliant with EU             regulations.

        https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search? filter=notificationStatusId:1,notificationLegislationId:34,choice:3

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