T/CAMDI 106-2023 Guidelines for controlling polymeric materials used in medical devices

Scope

Main technical content: This document explains and defines the term "polymer materials for medical devices", and provides control guidelines for polymer materials used in medical devices in accordance with the regulatory frameworks of China, the European Union, and the United States, in order to ensure the safety and effectiveness of the final medical devices. This document is applicable to stakeholders involved in polymer materials for medical devices who need to control the quality of these materials.

Development Information

Related Standards