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2022-09-05 | All chapters

High-end Medical Devices

High-end medical devices—such as software/artificial intelligence (AI)-based medical devices—continue to advance rapidly, and are now widely used in healthcare systems around the globe. However, the current regulatory system in China is still based on high-risk, hardware-based medical devices, which causes problems for manufacturers of software and AI-based high-end medical devices. Until China’s regulatory system is updated, Chinese patients may experience delays in accessing software and AI-based medical devices that have undergone critical software updates.

Since 2011, the European Chamber’s Healthcare Equipment Working Group has been promoting the application of international standards by relevant Chinese regulatory departments to help formulate an innovative registration review guideline for digital health products.

In March 2022, the National Medical Products Administration published three major guidelines, which made high-end medical device pre-market registrations much smoother, thereby increasing the accessibility of advanced high-end medical devices in the Chinese market.

Read the full story in English, or in Chinese.

For more information on the Healthcare Equipment Working Group, please click here.