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