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Companion Diagnostics (CDx)


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CDx Regulatory Landscape in China

CDx in China

The CDx reagents are regulated under IVD in China. Similar to the U.S., China categorizes CDx IVD reagents as high-risk products therefore designates them in Class III.

China NMPA was lagging behind its counterparts in the US and EU (?!) in issuing guidance regulating CDx products. But it is catching up recently. In China, there was no guidance specifically for CDx until NMPA published the “Revisions for instructions for use and technical review of tumor companion diagnostics based on similar therapeutic drugs (Draft)” on July 7, 2020 for public comments. About one month later, NMPA published another guideline for CDx clinical trials, “Clinical Trials Guidelines for Companion Diagnostic Reagents for Approved Anti-tumor Drugs (draft).” In addition, NMPA announced its preparation of “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs” on June 3rd, 2020.

The increased publication frequency of the CDx guidance in China suggests that NMPA CMDE is starting to pay more attention and intends to provide detailed regulation of CDx products.

How Can We Help?

Our Expertise

China Med Device (CMD) assists IVD and CDx manufacturers to comply with China regulations throughout the whole product life cycle. From preparing regulatory strategies, to providing registration/renewal/modification submission and post-marketing surveillance (PMS) services, we deliver unparalleled expertise. With proactive interactions with regulatory offices as well as the clients, CMD will enable your success on China entry.

Some of our core expertise are:

  • Product verification and validation
  • Gap analysis and regulatory strategy development
  • Classification identification
  • Clinical protocol design and execution of clinical trials
  • Predicate device identification, CER preparation
  • Registration/renewal/modification dossier preparation and consultation services.
  • PTR writing and testing related services (type testing, biocompatibility, stability etc.)
  • GMP/QMS, Certification & Compliance
  • Post Market Surveillance


To unlock the IVD/CDx China market, please contact

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