[Emergo, UL] How to Conduct a Known Problems Analysis (KPA) for NMPA Compliance

Why a known problems analysis is crucial for NMPA compliance

A known problems analysis (KPA) is a human factors engineering (HFE) activity that aims to identify use issues and user interface flaws with devices currently on the market. Regulators require medical device manufacturers to conduct a KPA to investigate use problems associated with devices that are similar to a device under development (i.e., that have similar user interface elements, user interactions, and/or user groups).  

 

Many manufacturers will be familiar conducting this process to align with the U.S. Food and Drug Administration (FDA) or IEC62336-1 requirements and will be well versed in identifying appropriate databases, identifying an appropriate time frame, and scoping the KPA according to the countries in which they intend to market the product.  

 

Notably, in March 2024, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) released a finalized version of its guidance pertaining to the application of HFE / usability engineering (UE) to medical device development. The NMPA guidance differs from IEC62366-1 and FDA guidance in a few areas, one of these being the expected scope of a KPA. Note that the NMPA refers to this activity as an “analysis of the post-marketing use of similar medical devices.” In this article, we discuss how the NMPA’s expectations for a KPA differ from the FDA and IEC-62366-1, and we highlight how to most efficiently conduct an NMPA-compliant KPA.  

 

 

Conducting a KPA for NMPA Compliance | EMERGO by UL

How to Conduct a Known Problems Analysis (KPA) for NMPA Compliance