我国《在用医疗器械检验技术要求》编制构想

On Compilation of Requirements on Inspection Technology for In-use Medical Devices in China

为更好地贯彻即将发布和实施的《医疗器械使用质量监督管理办法》,编制《在用医疗器械检验技术要求》迫在眉睫。本文介绍了我国《在用医疗器械检验技术要求》编制的初步构想,探讨了适合我国对在用医疗器械检验的新模式和新思路。

To better implement Regulations on Supervision of Usage Quality of Medical Devices that is about to be issued and enforced, it is urgent to compile Requirements on Inspection Technology for in-use Medical Devices. This article introduced the preliminary conception of compiling Requirements on Inspection Technology for inuse Medical Devices in our country and discussed new modes and new ideas suitable for testing in-use medical devices in our country.