A draft guidance paper on Human factors engineering has been published in China in May 2020.

The translation of the title of the guidance document, which is available in chinese only, is “Guidelines for the technical review of medical device human factors design”. The document is intended to receive comments from the medical device industry and is expected to be in final state in autumn. The guidance will be applicable for all class II and III devices following the chinese NMPA classification system (mid- and high-risk medical devices). The initial translation shows significant similarities with the US FDA guidance and the IEC 62366-1 standard.

Check our news for further details in the coming days.