Circular of the Department of General Affairs of the National Medical Products Administration on the Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System (Yao Jian Zong Xie Zhu [2018] No.43)

13 November 2018

The National Medical Products Administration has issued the Implementing Measures for the Reform of "Separating Business Licenses from Operating Permits" to Further Advance the Reform of the Medical Device Evaluation, Examination and Approval System on 13 November 2018. Specific measures include shortening the timeframe needed for the examination and approval, introducing optimal measures in favour of medical innovations and the marketing of medical device products urgently needed in clinical treatment, accelerating and optimizing the examination of a quality system to be registered and simplifying materials requested for the examination and approval.