"Xiaohua" Brand PVC Plastic for Blood (Infusion) Transfusion Devices – Blood Bag Formulation Registered with the National Medical Products Administration

The issue of excessive leaching of plasticisers and other harmful substances from PVC plastic blood bags in China has long been a concern. To strengthen regulatory oversight, the National Medical Products Administration (NMPA) introduced a requirement in 2003 for the registration of material formulation compositions and production processes for single‑use plastic blood bags. In accordance with these regulations, Yangzhou Kaier Chemical Co., Ltd. (the predecessor of Jiangsu Kaier Polymer Materials Co., Ltd.), as one of the three domestic manufacturers at the time, submitted its blood bag formulation and production process to the Medical Device Department of the NMPA on 31 May 2003.

This registration established standardised regulatory management requirements for the production of PVC blood bag materials, thereby ensuring safety throughout collection, transportation, storage, and use.