Human Factors Engineering in China

THAY Medical embarks on a new journey in the Chinese market by providing services to get approval from the National Medical Products Administration (NMPA) in China. We provide the service for registration of NMPAs with the co-operation of Auxergo, a UK- and Shanghai-based company.

Usability Testing in China

THAY Medical provides the service for registration of NMPAs with the cooperation of Auxergo. The registration of NMPA mostly requires local human factors tests, including participants from qualified testing institutes. The report shall come with a Chinese version, which THAY Medical and Auxergo are providing as well.


We provide expert NMPA registration for success in China.

Our China Services

China Market & User Research

China has accounted the largest population in the world, which indicates a large number of users in user research. However, the requirements for medical devices applied in China market would be different based on culture, language, training system, and geography. 

NMPA Regulatory Compliance

Despite the high compliance with FDA and IEC 62366, the NMPA has critical differences on sample size, study materials, document requirements, and medical device classification. There were cases failed due to the compliance issues with NMPA, which may become potential challenges to get into China market. The first step of success in China market is the compliance of NMPA, and THAY Medical can be the one to help.

NMPA Human Factors Report

The new-released NMPA draft has listed the required human factors documents – the documents needed for submission and registration. There additional materials are required for NMPA comparing with FDA for human factors report. Moreover, with the partnership with Auxergo, THAY Medical provides a series of human factors service, including the submission of Chinese report.

Human Factors Testing in China

To register medical devices in China, the local clinical tests are usually required with Chinese users. In addition, in order to leverage represented users, the qualified recruitment institute is crucial in getting NMPA approval. THAY Medical in the partnership with Auxergo can guarantee the represented participants and official-recognized recruitment system to ensure the testing quality in China.

Testimonials

  • “Every aspect of the study was conducted with professionalism, from the preparation of the test to the moderation and observation as well as the comprehensive debriefing. The participants were comfortable during the sessions, leading to good data quality on user-task and use-errors and accurate feedback. Overall, the performance was fantastic.”

    — The Validation Team, Large Medical Device Manufacturer.

  • "Great planning, organisation and performance. One of the best we have ever used. THAY Medical is a symbol for high quality work and is our preferred partner for usability testing.”

    — Regulatory Affairs Specialist, Medical Device Manufacturer.

  • “Very collaborative approach. High competency and efficiency. Everything was flawless. I’ll call on THAY Medical again in the future!”

    – Director of Research and Development, Medical Software Developer.

  • “THAY Medical are collaborative and pragmatic.”

    – Senior Regulatory Affairs Specialist, Medical Device Manufacturer.

Get in touch

If you would like to find out more about how we can help make a difference for your medical products, please don’t hesitate to reach out and we’d be happy to chat.