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2024 China NMPA Bluebook is here:

NMPA to Down-Classify Certain Cancer Biomarker Reagents


NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. The impacted reagents include but not limited to the following:

  • Carcinoembryonic Antigen (CEA) detection Reagent
  • Cytokeratin 19 fragment (CYFRA21-1) detection reagent
  • Squamous cell carcinoma antigen (SCC) detection reagent
  • Neuron-specific enolase (NSE) detection reagent
  • Human epididymis protein 4 (HE4) detection reagent
  • Cancer antigen (CA125) detection reagent
  • Cancer antigen 15-3 (CA15-3) detection reagent
  • Calcitonin detection reagent
  • Aromatic sulfatase detection reagent

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.  NMPA tends to consolidate requests of the reclassifications for feedback and then issue a more comprehensive classification catalogue update over a year or more time period.  This down-classification notice for feedback is described as a dynamic process.  It is trying to balance the risk and benefit more efficiently and faster access to patient needs.   With NMPA recent announcements in real-world data and post-market data evaluation, different market entry strategies could be deployed. If finalized, it will reduce costs and time for the IVD manufacturers. Class III and class II submission requirements in documentation, testing and clinical evaluation are different, almost like PMA and 510K in the US.

The NMPA welcomes comments regarding this notice. If you have any questions about the proposed reclassifications, please contact us at We will consolidate the opinions and submit to NMPA.

For slides on China IVD Registration: Overview & Updates, please email us at

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About ChinaMed Device, LLC 

ChinaMed Device, LLC ( provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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