新医疗器械监督管理条例概要

On 18 March 2021, the State Council promulgated the Regulations on Supervision and Administration of Medical Devices (Revised in 2021), which will take effect on 1 June 2021 (the "New Medical Device Regulations"), to replace the existing Regulations on Supervision and Administration of Medical Devices, effective on 4 May 2017 (the "Old Medical Device Regulations"). The New Medical Device Regulations provide comprehensive provisions on encouraging medical device innovation and development, full life cycle quality supervision, clinical evaluation of medical devices, conditional approvals, emergency use authorization, registration and filing formalities, liabilities and punishments for violation, etc. In this regard, we intend to sort out some of the prominent highlights on the New Medical Device Regulations. Please click here to read.