Module 14: Design Development and Certification of Medical Devices

China – the latest Human Factors needs NMPA Human Factors requirements:

▪ Involves class II and class III medical devices only.

▪ Requires human factors studies in China with Chinese populations.

▪ Requires a minimum of 15 participants per user group in a Summative Human Factors study, but very strongly recommends 20 participants per user group.

▪ For legacy/mature devices and systems, a comparative human factors evaluation is recommended.

▪ The guidance details high-risk medical devices (generally class III devices)

▪ It is still a draft but is in a second round of feedback.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development