人工智能医疗器械监管研究进展

Progress in Regulatory Research of Artificial Intelligence Medical Devices

人工智能医疗器械具有自身特性,其监管问题已成为国际医疗器械监管领域的研究焦点之一,亟需深入研究。本文介绍了人工智能医疗器械所面临的监管挑战,提出了人工智能医疗器械监管的总体思路,在分类界定、技术审评、体系核查等方面重点讨论了人工智能医疗器械的监管考量,并就今后的人工智能医疗器械监管研究方向提供相关建议。

Artificial intelligence medical devices have their own characteristics,and their regulation has become one of the focuses of international medical device regulation,which needs further research.This article introduces the regulatory challenges of artificial intelligence medical devices,puts forward the general approach for the regulation of artificial intelligence medical devices,discusses the regulatory considerations on artificial intelligence medical devices in terms of classification,technical review and inspection,and finally provides suggestions for future regulatory research on artificial intelligence medical devices.