In vitro diagnostic reagents classification subdirectory 2020

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In: Medicine/medical devices, registration
The National medical product administration issued a public announcement to adjust in vitro diagnostic reagents classification sub catalog (2013 Edition)” on 28,November. 29 IVD reagent categorized as III-7 were adjusted from class III to class II, and the corresponding expected uses were also adjusted.Among the 29 IVD reagent products, 25 of them are non-clinical IVD products. After the adjustment of the remaining four products from category III to category II, the sample size required for clinical trials will also be reduced.The registered IVD reagents is adjusted from high-level management category to low, the medical device registration certificate within the validityRead More →

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