Sep 4, 2020

New guidance on medical device usability testing from China’s National Medical Products Administration (NMPA), anticipated to be issued in late 2020, will entail compliance challenges as well as commercial differentiation opportunities for manufacturers.

According to Emergo by UL sources in Beijing and Shanghai, NMPA's guidance will hew closely to usability testing requirements and recommendations established by the US Food and Drug Administration and other regulators, as well as align with reference standards including ISO 60601, IEC 62366 and ANSI/AAMI HE75. However, NMPA will also include requirements specific to the Chinese market that foreign manufacturers will need to meet in order to help achieve and maintain device registration.

Emergo by UL will provide in-depth analysis of the new NMPA usability testing guidelines following their publication. In the meantime, we’ll examine two key themes that manufacturers based outside of China in particular should consider.

In-country testing requirements

First, foreign manufacturers may have to conduct human factors design validation and usability testing in China if their devices have not previously underwent such testing with Asian populations. Unless China medical device market applicants can provide data from usability tests conducted on Asian subjects, those companies should gear up to run usability testing in the country in order to meet these new guidelines and obtain or maintain NMPA registration.

Device size: designing based on regional preferences?

Second, the NMPA guidance on usability testing targets the people who will use medical devices more so than the devices themselves. In other words, the new guidelines may address needs for medical devices to be more closely tailored to the characteristics of particular regions within China. These requirements would reflect intentions to optimize medical products according to regional preferences, and ensure that manufacturers accommodate large and diverse populations in China.

Ryan Zhang is Business Development Manager and Stewart Eisenhart is Manager, Copy/Editorial at Emergo by UL.

Additional human factors engineering and Chinese medical device regulatory resources:

  • Human factors engineering user research for medical devices, IVDs and combination products
  • Human factors design and prototype development
  • China NMPA medical device registration and approval consulting
  • Webinar: Medical device registration requirements in China
  • Whitepaper: Common use errors and design considerations for combination products

 

 

 

Author

  • Ryan Zhang and Stewart Eisenhart

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