Aug 25, 2022

 

Emergo by UL and the Shanghai Center for Medical Testing and Inspection (CMTC) stand ready to help customers develop products that meet the needs and preferences of medical device users in China. The collaboration of the two organizations enables usability testing in accordance with the human factors engineering (HFE) guidance set forth by China’s National Medical Products Administration (NMPA).  

The NMPA guidance stresses the importance of considering several different factors that, if not properly accounted for, could increase the likelihood of use-related issues. Such differences typically vary by region and include culture, language and common units of measurement. Intended users (specifically, residents in various regions of China) must be able to use imported medical devices safely and effectively. For these reasons, the NMPA guidance states that summative usability testing of imported medical devices should be performed in China unless sufficient supporting evidence can be provided that any differences between China’s and foreign countries’ users and use environments will have no significant appreciable effect on user performance.

The collaboration between Emergo by UL and the CMTC, announced in 2020, is already paying dividends for medical device developers. 

Recently, a leading medical device manufacturer sought Emergo by UL’s help in responding to China’s HFE guidance. In particular, the customer asked us to interpret China’s HFE expectations and determine the best course of action for some of their products. In one instance, Emergo was able to help collect evidence that there was no significant difference in user performance when comparing China users with other countries. Emergo crafted a justification documenting this evidence allowing the customer to forgo summative testing in China.  

In another case involving a surgical system, equivalence could not be established. Therefore, we immediately worked with CMTC to conduct a summative usability test of the system in CMTC’s extraordinarily well-equipped medical simulation center. Accordingly, our collaboration provided the customer with an immediate solution for testing in-country and fulfilled the NMPA’s requirements for usability test data to be produced in a government-sponsored lab.  

Due to the close collaboration between Emergo, CMTC and the customer, the summative usability test of the system proceeded smoothly, involving appropriately qualified physicians and supporting personnel. These partnerships are critical to the success of meeting the nuanced expectations of NMPA and bringing new medical devices to market in China. 

We invite you to consider how Emergo by UL and CMTC can help you. 

Michael Wiklund is General Manager and Director, Human Factors Research & Design (HFR&D) at Emergo by UL.

Additional medical device human factors engineering and usability resources from Emergo by UL:

  • HFE user research for medical devices, IVDs and combination products
  • Human factors design and prototype development support
  • Webinar: Conducting usability tests in China

Author

  • Michael Wiklund

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