China CDx Registration

Using Western CDx products, drug companies and their specific drug products can more easily target the right patients with specific diseases.

Unfortunately, CDx registration in China is still evolving. Currently, CDx products in China are classified as medical device or IVD products.

On June 3, 2020, China’s NMPA’s Center for Medical Device Evaluation (CMDE) issued its first guideline for CDx products via – Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor drugs. In addition, the CMDE published the following CDx guidelines:

  • Technical Review of CDx for the Same Kind of Therapeutic Drug, July 2020
  • Guidance for Clinical Study of CDx for the Marketed Oncology Drugs, August 2020

Most CDx products in China are classified as Class 3 medical devices or IVDs. Since registration in China of Class 3 medical devices or IVDs takes a long time, drug and CDx developers must work together to be successful with product registration. In addition, current problems with CDx’s in China include the shortage of trained pathologists for these types of products and the fact that most Chinese labs have different tests and equipment.

In the future, the Chinese NMPA and CMDE will increase regulations and streamline registrations of CDx products. Pacific Bridge Medical can help Western CDx manufacturers register their CDx products in China.