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Jasmin Hunter • Michael Yan
Feature Articles | 17 September 2019 | Citation
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.