On October 24, the Shanghai Drug Administration and other four provincial bureaus jointly issued a document and released the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in the Yangtze River Delta Region." The plan clarifies the responsibilities and obligations of the registrant and the entrusted company, as well as the division of responsibility for cross-regional supervision. Original plan:
Notice of Shanghai Municipal Drug Administration, Jiangsu Provincial Drug Administration, Zhejiang Provincial Drug Administration, Anhui Provincial Drug Administration, on Issuing the "Implementation Plan for the Pilot Work of the Registrant System for Medical Devices in the Yangtze River Delta Region" (Shanghai Drug Administration (2019) ] No. 112)
All related units:
In order to thoroughly implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Drug and Medical Device Innovation" issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council (Ting Zi  No. 42), in accordance with the "Regarding Expansion of Medical Treatment The “Notice on Pilot Work for Device Registrants” (Guoyao Jianxi Zhu  No. 33) requires that the high-quality integrated development of the medical device industry in the Yangtze River Delta region be promoted, and further experience will be accumulated for the comprehensive implementation of the medical device registrant system across the country. The Municipality, Jiangsu Province, Zhejiang Province, and Anhui Province Drug Administration have reached an agreement to formulate the "Implementation Plan for the Pilot Work of the Medical Device Registrant System in the Yangtze River Delta Region", which is hereby issued to you, please implement it carefully.
Attachment: Implementation plan for the pilot work of the medical device registrant system in the Yangtze River Delta (omitted).
Shanghai Municipal Drug Administration Jiangsu Provincial Drug Administration
Zhejiang Provincial Drug Administration Anhui Provincial Drug Administration
October 24, 2019