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BioWorld - Saturday, June 6, 2026
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Home » China’s NMPA may expect domestic HFE work for imported devices
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China’s NMPA may expect domestic HFE work for imported devices

April 23, 2024
By Mark McCarty
China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation.
Medical technology Regulatory Asia-Pacific China NMPA

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