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Four Data Management Guidelines Issued for Devices and IVDs, Propelling China to be the Leader of Medical Information Technology

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The NMPA issued four data management guidelines on August 15, 2023. These documents are formulated to facilitate the information technology infrastructure for medical device registration and filing, encompassing both domestic and imported medical devices falling under Class I, Class II, and Class III.

  • Basic dataset for registration and filing management of medical devices
  • Basic dataset for registration and filing management of in vitro diagnostic reagents
  • Medical devices (including in vitro diagnostic reagents) regulatory information basic data element (registration and filing part)
  • Medical devices (including in vitro diagnostic reagents) regulatory information basic data element value field code (registration and filing part)

For an English copy of any guidelines above, please contact us by emailing info@ChianMedDevice.com. We charge nominal fees for the translation.

Significance of the NMPA Data Management Guidelines

These documents establish standards for the identification of data elements, including their Chinese names, short names, definitions, data types, representation formats, allowable values, units of measurement, versions, and sources. These standards are applicable to the identification, exchange, and sharing of information related to medical devices and IVD products.

Also, they define the code domains for data elements used in the regulation of medical device and IVD registrations. These code domains are essential for representing, exchanging, identifying, and processing information related to medical devices and IVD.

Allowing for consistency and accuracy in information exchange, they provide a structured framework for classifying datasets and ensure that data elements are clearly defined. These standards enhance the efficiency and effectiveness of regulatory processes, ultimately contributing to the safety and quality of medical products in the healthcare industry.

Outline of “Basic Dataset for Registration and Filing Management of Medical Devices”

Medical Device Registration Basic Information Data Subset

  • Class II and Class III Medical Device Registration Certificate Information Data Subset
  • Class II and Class III Medical Device Change Registration (Filing) Document Information Data Subset
  • Class II and Class III Medical Device Registration Application Basic Information Data Subset
  • Class II and Class III Medical Device Registration Application Data Subset
  • Class II and Class III Medical Device Change Registration Application Data Subset
  • Class II and Class III Medical Device Change Filing Data Subset
  • Class II and Class III Medical Device Continuing Registration Application Data Subset
  • Class II and Class III Medical Device Withdrawal/Reissue/Correction/Cancellation Application Data Subset
  • Class II and Class III Innovative Medical Device Special Approval Application Data Subset
  • Class II and Class III Medical Device Clinical Trial Approval Application Data Subset
  • Class II and Class III Medical Device Instruction Manual Change Application Data Subset

Medical Device Registration Form/Filing Review and Acceptance Data Subset

  • Medical Device Registration Technical Evaluation Data Subset
  • Administrative Approval Information Data Subset for Medical Device Registration

Medical Device Filing Management Data Subset

  • Class I Medical Device Filing Information Table Data Subset
  • Class I Medical Device Filing-Related Data Subset
  • Class I Medical Device Filing Data Subset
  • Class I Medical Device Change Filing Data Subset
  • Class I Medical Device Cancellation Filing Data Subset

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