Regulatory responses and approval status of artificial intelligence medical devices with a focus on China

Abstract

This paper focuses on how regulatory bodies respond to artificial intelligence (AI)-enabled medical devices. To achieve this, we present a comparative overview of the United States (USA), European Union (EU), and China. Our search in the governmental database identified 59 AI medical devices approved in China as of July 2023. In comparison to the rules-based regulatory approach in China, the approaches in the USA and EU are more standards-oriented.

Fig. 1. Overview of NMPA working framework and current progress on regulations and standards applicable to AIMDs.

NMPA National Medical Products Administration, AIMD artificial intelligence medical device, DL deep learning, CT Computed Tomography, CADx Computer-Assisted Diagnosis, CADe Computer-Assisted Detection, AI artificial intelligence, CTA Computed Tomography Angiography.

Fig. 2. Selection flowchart for inclusion of AIMDs approved by the NMPA.

NMPA National Medical Products Administration, AIMD artificial intelligence medical device, IT Information Technology, AI artificial intelligence.

Fig. 3. 59 NMPA-approved AI/ML-based medical devices.

Features shown in the figure include approval years, descriptions of AI-enabled medical technologies, and related medical specialties. NMPA National Medical Products Administration, AIMD artificial intelligence medical device, AI/ML artificial intelligence and machine learning, CT Computed Tomography, FFR Fractional Flow Reserve, ECG Electrocardiogram.

Fig. 4. The geographic distribution of origin cities for the 59 NMPA-approved AIMDs.

NMPA National Medical Products Administration, AIMD artificial intelligence medical device.

Fig. 5. A visualization of leading manufacturers and their numbers of approved AIMDs for each type.

The types are classified by the hardware and the fill color gradation in each tile represents different numbers of AIMDs which are added to each tile. The top plot shows the total number of approved AIMDs for each manufacturer. AIMD artificial intelligence medical device. CT Computed Tomography, ECG Electrocardiogram, X-ray X-radiation.

Fig. 6. Types of data based on which the approved AIMDs were developed.

AIMD artificial intelligence medical device, CT Computed Tomography, ECG Electrocardiogram, X-ray X-radiation.

Fig. 7. Time difference between common AIMDs in FDA and NMPA approval time (months).

The labels in y axis denote the device names with manufacturers in parentheses. AIMD artificial intelligence medical device. FDA US Food and Drug Administration, NMPA National Medical Products Administration. AI artificial intelligence, FFR Fractional Flow Reserve, ECG Electrocardiogram.