Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 17 September 2019 | By Jasmin Hunter, Michael Yan
Clinical Evaluation Process in China
Similar to EU requirements, clinical data requirements in China are broken down by device classes, with Class II and III devices requiring clinical data. In China, Class I devices require only a basic clinical description. The process begins with a review of the New Device Clinical Trial Exemption Catalogues. These catalogues have been available since 2014 and new ones are routinely published. The catalogues contain a list of product types that do not require clinical trial data or clinical evaluation report. Instead, documentation of two comparisons is required, the first being a basic comparison of the product under evaluation with a similar product type listed in the catalog. The second is a comparison of the device under evaluation with an equivalent device approved in China. Figure 1 provides an overview of the clinical evaluation process in China.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.