{
  "abstract": "Purpose: Revealing the key direction and regulatory measures of medical device policies can provide a scientific basis for improving the regulatory system and promote the healthy and orderly development of the medical device industry.\n\nMaterials and Methods: Collecting 37 medical device policy (2014–2025) at the central government level, which are currently in effect or will soon come into effect, this study adopts the BERTopic model to extract topics. Through analysis of thematic content, hierarchical structures, and clusters, it provides a comprehensive decoding of Chinese medical device policy texts.\n\nResults: A total of 17 topics have been identified in the medical device policy. Based on the correlation of the hierarchical structure of these topics, they are classified into six clusters: advertising regulations, subject qualifications and compliance requirements, application template, clinical trial management, comprehensive regulatory system, storage and transportation technical specifications.\n\nConclusion: The topic modeling of the policy text on medical devices reveals the focus areas, policy intentions, and regulatory priorities, providing a scientific basis for improving the regulatory framework.",
  "abstract_shown": true,
  "affiliations": [
    "Zhejiang Institute of Medical Device Supervision and Testing, Hangzhou, People’s Republic of China",
    "NMPA Key Laboratory for Biomedical Optics, Hangzhou, People’s Republic of China",
    "Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province, Hangzhou, People’s Republic of China",
    "School of Business, Jiangnan University, Wuxi, People’s Republic of China",
    "School of Public Administration, Zhejiang University of Technology, Hangzhou, People’s Republic of China",
    "School of Management, Zhejiang University of Technology, Hangzhou, People’s Republic of China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 3,
  "authors": [
    {
      "affs": [
        0,
        1,
        2
      ],
      "name": "Xin Lu"
    },
    {
      "affs": [
        3
      ],
      "name": "Jiawei Chen"
    },
    {
      "affs": [
        4,
        5
      ],
      "name": "Yang Miao",
      "orcid": "0000-0001-6405-3898"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/0dgj4ahad3mys.bib",
  "cited_by": 0,
  "doi": "10.2147/mder.s643805",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13738262/",
  "id": "0dgj4ahad3mys",
  "issns": [
    "1179-1470"
  ],
  "landing_url": "https://doi.org/10.2147/mder.s643805",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Research"
    ],
    [
      "openalex",
      "2739|Healthcare Regulation"
    ]
  ],
  "openalex": "W7224996408",
  "pdf_url": null,
  "pmcid": "PMC13738262",
  "pmid": "42992221",
  "published": "2026-11-01",
  "publisher": "Dove Press",
  "ris": "https://research.draconitic.com/paper/0dgj4ahad3mys.ris",
  "sources": [
    {
      "first_seen": "2026-11-09T12:23:16Z",
      "native_id": "PMC13738262",
      "source": "pmc",
      "url": "https://doi.org/10.2147/mder.s643805"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2739|Healthcare Regulation",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Topic Modeling and Content Analysis of Chinese Medical Device Policies Using BERTopic",
  "title_text": "Topic Modeling and Content Analysis of Chinese Medical Device Policies Using BERTopic",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:23:16Z",
  "url": "https://research.draconitic.com/paper/0dgj4ahad3mys",
  "venue": "Medical Devices (Auckland, N.Z.)",
  "versions": []
}