Evaluation Method Establishment and Characterization of Unknown Leachables in Medical Devices

On June 24, 2020, CMDE start to collect comments on the Technical Review Guideline for Evaluation Method Establishment and Characterization of Unknown Leachables in Medical Devices (Draft). This guideline can apply to medical device registration or product development process. For different evaluation purposes, this guideline can provide reference for the evaluation method establishment and characterization of the unknown leachables in medical devices. If you are related to the study of unknown leachables, your comments or opinions about this Guideline can be submitted by July 30, 2020, via email.

Link: https://www.cmde.org.cn/CL0004/21163.html