China – New Medical Device Regulations

On 18 March 2021, the State Council promulgated the Regulations on Supervision and Administration of Medical Devices, which will take effect on 1^st June 1st, 2021 (the “2021 Regulations”).

Compared with the existing Regulations on Supervision and Administration of Medical Devices (lastly revised in 2017), the 2021 Regulations focuses more on innovation and development of the medical device industry, as well as quality and safety of medical device products.

We briefly summarize the amendments brought by the 2021 Regulations in this newsletter.

This newsletter is the first newsletter of our serie 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

The series

Medical Devices – Clinical Evaluation and Clinical
Trials

On the Medical Device Registrant System in China

On Online Sales of Medical Devices in China