Researchdeep learningradiologycomputed tomography
China Records Rising AI Medical Device Approvals
9.2
Researchers analyzed Drugdataexpy and NMPA records to identify AI-based medical devices approved in China through June 30, 2025, finding 154 approvals since 2020. Approvals rose from 9 in 2020 to 45 in 2024, with 79.9% classified as class III and deep learning and radiology (CT) dominating; clinical trials were the primary evaluation pathway. The study highlights market concentration among a few manufacturers in major Chinese hubs.
Key Points
- 1Identify growth: 154 AIMDs approved in China from 2020 to June 2025, rising annually.
- 2Show regulatory alignment: 79.9% class III devices, indicating risk-proportionate review and clinical trial emphasis.
- 3Implication for practitioners: Radiology and CT dominate (68.8%, 62.3%), guiding development and deployment priorities.
Scoring Rationale
High-quality peer-reviewed nationwide dataset yields strong industry-wide relevance, limited by descriptive analysis rather than causal evaluation.
Sources
Public references used for this report.
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