State Administration for Market Regulation, Measures for the Administration of the Registration and Record Filing of Medical Devices

国家市场监督管理总局医疗器械注册与备案管理办法

September 24, 2021 | BY

Susan Mok

New rules allow for priority registration of medical devices

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Promulgated: August 26, 2021

Effective: October 1, 2021

Main contents: Where a medical device satisfies the following requirements, the applicant may apply for application of the registration procedure for innovative products:

(1) through its self-directed technical innovation activities, the applicant lawfully owns the invention patent for the core technology in its products in