Six AI Guidelines Issued for Medical Device Software in 2023, Propelling China to be World Leader

NMPA affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform summarized six AI related guidelines released in 2023. These documents are “based on the characteristics of AI medical devices, clarifying the technical review requirements, including general and key product requirements, and building a standard system to enhance China’s AI industry development and international influence in the space”, the platform says.

Complete List

• Key Points on Clinical Evaluation of AI-assisted Detection Medical Devices (Software)
• Key Points on Review of Imaging Ultrasound AI Software (Process Optimization)
• Key Points on Performance Evaluation Pathological Image AI Analysis Software
• Key Points on Clinical Evaluation of Pathological Image AI Analysis Software
• Key Points on Performance Evaluation of AI Analysis Software for Blood Disease Flow Cytometry
• Key Points on Review of Magnetic Resonance Imaging System AI Software Functions

For an English copy of any guidelines above, please email info@ChinaMedDevice.com.

For our comprehensive review of Clinical Evaluation of AI-assisted Detection Medical Devices (Software), please click HERE

For Review of Imaging Ultrasound AI Software (Process Optimization), click HERE

For Review of Magnetic Resonance Imaging System AI Software Functions, click HERE

View the “Guideline for Artificial Intelligence Medical Devices”

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• Source: https://chinameddevice.com/six-ai-guidelines-2023/