State Council, Regulations for the Regulation of Medical Devices (Revised in 2021)

国务院医疗器械监督管理条例 (2021年修订)

April 16, 2021 | BY

Susan Mok

Laboratory-developed tests are given the green light

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Promulgated: February 9, 2021

Effective: June 1, 2021

Main contents: Class 1 medical devices shall be subject to administration by means of product record filing, whereas Class 2 and Class 3 medical devices shall be subject to administration by means of product registration.

A medical device registrant or record filer shall strengthen management of the quality of such device throughout its life cycle and bear