In March 2021,the National Medical Products Administration issued an announcement regarding the registration system of medical device master files.This announcement aimed to strictly differentiate medical materials from materials used in other application areas.However,there is currently no standard to define the requirements for medical grade materials in China.Therefore,under the leadership of the Medical Polymer Products Branch of China Association for Medical Devices Industry,14 relevant organizations from the user and production sides of medical-grade polymeric materials jointly developed the"Guidelines for the control of polymeric materials for medical devices"(T/CAMDI 106-2023).This group standard fills the gap in the existing standards and becomes the first guiding document specifically addressing polymeric materials for medical devices in China.The guidelines provide explanations and definitions for polymeric materials used in medical devices and propose basic requirements for formula consistency,safe supply,and change management of such materials.The document establishes a unified guide for the control and evaluation of polymeric materials used in medical devices.The article introduces the implementation plan for the standard and emphasizes that the adoption and implementation of the guidelines will have a profound impact on the entire medical device industry.
polymeric materials for use in medical devicesconsistencysafetymaster filequality assurance agreement
维普
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