[Emergo, UL] Webinar: Insights and expertise gained from a year of applying the 2024 HF guidance

Emergo에서 아래와 같이 웨비나를 개최한다.

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▶ 주제: Determining when to utilize the pre-submissions Q-submission (Pre-Sub) Process

▶ 일시: 2025년 03월 12일 CST 9시 (한국시간: 03월 12일 23시)

 

 

China’s medical product regulator, the National Medical Product Administration (NMPA), finalized their Human Factors (HF) guidance “Guidelines for the review of medical device usability engineering registration” in March 2024. The guidance came into effect on October 8, 2024, after a 6-month grace period. As such, manufacturers that want to market their medical products in China must meet NMPA’s HF expectations set forth in their finalized HF guidance document.

 

In this presentation, the presenters will briefly review the HF expectations and activities set forth in NMPA’s 2024 HF finalized guidance and share their experiences in meeting NMPA’s HF expectations during the guidance document’s inaugural year. 

 

 

Insights and expertise gained from a year of applying the 2024 HF guidance | Emergo by UL

Insights and expertise gained from a year of applying the 2024 HF guidance