Frequently Asked Questions about China China Human Factor/Usability Studies:
Is the new NMPA Human Factor Guideline applicable to combination products, specifically injectables like prefilled syringes or autoinjectors?
The NMPA usability engineering guideline published in Mar 2024 does applicable for combination products. The device part of the combination product needs to be in compliance with this guideline. Generally, pre-filled syringes (non-active devices) are regulated as devices with medium/low use related risks. the applicant only needs to submit a product use error evaluation report together with the US usability engineering documents. For pre-filled auto injectors, depending on the application scope, the risk level may be different. If the product is considered as devices with high use related risks, a usability engineering research report should be submitted for product registration.
In principle, for the China medical device market submission, the applicant needs to perform relevant user interface validation work in China, regardless of whether the legal manufacturer is in China or the US. User interface validation work ≠ user interface validation testing (summative usability testing). For products with medium or low use-related risk, generally, the applicant only needs to submit a product use error evaluation report together with the US usability engineering documents.
For products on the “Catalog of product with high use-related risk (Trial)”, if the applicant only performed the summative usability testing in the US, the applicant should conduct a usability engineering gap analysis regarding the differences of the intended users, use scenario, guideline requirements between China and US. The difference to be evaluated include the type of critical tasks, the scope of intended users, the scope of operation tasks, clinical practice, etc. Based on the results of the gap analysis, if the risk of the impact of differences between China and US on user interface validation is acceptable (Scenario 1), the applicant does not need to re-validate the use interface in China. If the risk is not acceptable (Scenario 2), the applicant needs to re-validate the use interface in China. It could be a complete re-validation or partial re-validation (for the identified gaps only). For both scenario 1 and scenario 2, the gap analysis report needs to be submitted together with the user interface validation documents.
Re-validation does not mean that you need to redo the user interface validation testing in China. As introduced in the webinar, if there are equivalent devices already approved in China, the documents of the equivalent devices can be used as alternative too. Depending on whether there are differences between the equivalent device and the product to be registered or whether new risks are introduced, additional validation testing may be required.
China Med Device can help to evaluate your usability documents currently available to see whether a China user interface validation testing is recommended at this stage. Please email us at info@ChinaMedDevice.com if you would like to have further discussion.
