NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24th, 2020. It is part of China NMPA massive reclassification plan to accelerate the process of introducing in-demand medical device/IVDs to China market. The reagents include but not limited to:
- 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
Besides the reclassification, China NMPA is also taking efforts to reduce the market entry time by accepting real-world data and post-market data for clinical evaluation. I would love to hear your actual experiences or cases.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------