Home » China SFDA’s Draft List of IVD Reagent Classifications a Mixed Bag for Industry
China SFDA’s Draft List of IVD Reagent Classifications a Mixed Bag for Industry
China’s State Food and Drug Administration (SFDA) has wrapped up a public consultation on the reclassification of 745 in vitro diagnostic (IVD) reagents as part of an effort to develop a more sophisticated device classification system. But some industry groups had hoped the draft list would go farther to ease requirements for low-risk products. The list adds two new classification categories: Reagents related to flow cytometry will be regulated as Class III devices and reagents used for extraction and purification will be Class II.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
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