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26 June 2021

China – Medical Devices – Clinical Evaluation and Clinical Trials : Balance between Safety and Innovation before Marketing

Second newsletter of our series dedicated to Medical Devices Regulation in China further to the promulgation of the Regulations on Supervision and Administration of Medical Devices, which entered into force on June 1st, 2021.


In this newsletter we will take a closer look at clinical evaluation and clinical trials.


The 2021 Regulations encourages, through different measures, innovation and development of the medical device industry, Chinese regulators intending to maintain the delicate balance between safety and innovation in this area. The rules related to clinical evaluation and clinical trial for medical devices are in this framework.


The series

On New Medical Device Regulations in China

On the Medical Device Registrant System in China

On Online Sales of Medical Devices in China

DS China Newsletter

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