Course Description

Pre-Market Approval for Medical Device in China

Course Description:

This course offers you an excellent overview of the Chinese regulatory system for medical devices and outlines the pathways to access the medical device market in China. Starting with a detailed explanation of the Chinese regulatory system, this course also examines the process for registration of your devices including the post-market surveillance requirements you will need to fulfill. PLEASE NOTE THAT THIS COURSE IS GOING THROUGH UPDATES. For the meantime, note that the SFDA has changed names and is now known as Chinese State and Food Administration. 

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Comprehend and define the working fundamentals of the Chinese regulatory system for medical devices and navigate the steps for market access.

Who Should Enroll:

Regulatory affairs professionals involved in registration and market access for China.

Prerequisite Knowledge/Requirements:

Understanding the main principles of market access for medical devices as outlined by the GHTF (IMDFR).

Basic knowledge of market access for medical devices with one of the GHTF (IMDRF) members.

Subject Matter Expert:
Davey Han

53 min

Release date:

Related resources:

Case studies:

Peer review:
Lucy Xiao

Change Currency:
Under review !!