AI Guidelines 2023
The NMPA (National Medical Products Administration) affiliated Artificial Intelligence Medical Device Innovation Cooperation Platform has provided a comprehensive summary of six pivotal AI-related guidelines released in 2023. These guidelines, significant in their scope and detail, primarily focus on the unique aspects of AI medical devices. They serve to clarify the technical review requirements that are essential for this sector. This includes both general and specific product requirements, ensuring that a broad spectrum of devices is covered. Importantly, these guidelines are a step towards establishing a robust standard system. This system is aimed at not only enhancing the development of China’s burgeoning AI industry in the medical field but also at amplifying its international influence. As the AI technology landscape evolves rapidly, these guidelines are seen as a crucial move in aligning China’s AI medical devices sector with global best practices, thereby facilitating international collaboration and setting benchmarks for quality and innovation.
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 AI Guidelines 2023 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”
