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The NMPA Down-Classified Certain Cancer Biomarker Reagents


With an announcement on October 20, 2020, the NMPA reclassified 29 cancer biomarker-related reagents from Class III to Class II. Additionally, they modified its intended use. The draft version for industry comments was released on April 24, 2020.

NMPA Cancer Biomarker Reagants

The impacted reagents include but are not limited to the following:

  1. Carcinoembryonic Antigen (CEA) detection reagent
  2. Cytokeratin 19 fragment (CYFRA21-1) detection reagent
  3. Squamous cell carcinoma antigen (SCC) detection reagent
  4. Neuron-specific enolase (NSE) detection reagent
  5. Human epididymis protein 4 (HE4) detection reagent
  6. Cancer antigen (CA125) detection reagent
  7. Cancer antigen 15-3 (CA15-3) detection reagent
  8. Calcitonin detection reagent
  9. Aromatic sulfatase detection reagent
  10. And more…

The announcement also specifies the regulations applicable for IVD registration, certificate validation for registered IVD, and the requirements for renewal.

For the complete list, or if you have similar cancer biomarkers entering China, please email

Implications of the Down-Classification

Along with the massive reclassifications of medical devices in August 2017, this proposal is part of the NMPA’s goal to be more dynamically adapting to the market needs to introduce needed device to the market faster.

Within just half a year, the NMPA has consolidated requests for feedback and issued the comprehensive classification catalog update. It is trying to balance the risks and benefits more efficiently and getting patient faster access to cancer diagnostics.

With the NMPA’s recent announcements in real-world data and post-market data evaluation, different market entry strategies could be deployed. The finalized re-classification will reduce costs and time for IVD manufacturers.

Class II and Class III submission requirements for documentation, testing, and clinical evaluation are different, just like PMA and 510K in the US.

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