Reshaping the Regulatory Landscape for the Chinese MedTech Industry

May 20, 2021 | BY

Susan Mok

Ting Wu of Haiwen & Partners discusses how the recently introduced Medical Device Regulations will impact consumers and companies in the MedTech industry by highlighting major breakthroughs provided by the legislation while at the same time striking a balance with compliance

The Chinese government recently released the new Regulations for the Regulation of Medical Devices, which will become effective on June 1, 2021, (the New MDR) (医疗器械监督管理条例) to replace the current Medical Device Regulations amended in 2017 (the Old MDR).

The New MDR, which is a fundamental piece of legislation for medical device regulation, has restructured the medical device legal framework in China. The New MDR reflects Chinese regulator's intention and efforts to strike an appropriate balance between innovation and compliance. It would foreseeably generate a sweeping impact on business strategy for both R&D assets, as well as mature brand assets.

The New MDR provides multiple green channels to accelerate patients in China access to innovative products with clinical values either prior to or after-market authorization granted by NMPA

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