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

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.

This premium content is reserved for
China Law & Practice Subscribers.

  • A database of over 3,000 essential documents including key PRC legislation translated into English
  • A choice of newsletters to alert you to changes affecting your business including sector specific updates
  • Premium access to the mobile optimized site for timely analysis that guides you through China's ever-changing business environment
For enterprise-wide or corporate enquiries, please contact our experienced Sales Professionals at +44 (0)203 868 7546 or [email protected]