Shanghai Pharmaceutical Administration and Equipment Management [2020] No. 67
All relevant units:
In order to standardize the supervision and management of cross-regional entrusted production of medical deviceregistrants and promote the cross-regional supervision of medical devices in the Yangtze River Delta region, accordingtothe”Opinions of the General Office of the Central Committee of the Communist Party of China and the General Office of theStateCouncil on Deepening the Reform of the Review and Approval System to Encourage the Innovation of Drugs and Medical Devices” “Medical Regulations on the Supervision and Administration of Devices, “Notice on Expanding the Pilot Work of theMedical Device Registrant System”, “Notice on the Release of the “Implementation Plan for the Pilot Work of the Medical DeviceRegistrant System in the Yangtze River Delta Region”, and specially formulated the “Medical Device Registrant SystemintheYangtze River Delta Region” The Measures for Cross-regional Supervision (for Trial Implementation)” are hereby issuedtoyou, please implement them conscientiously.
Annex: Measures for the Cross-Regional Supervision of the Medical Device Registrant System in the Yangtze River DeltaRegion (for Trial Implementation)
Shanghai Municipal Drug Administration Jiangsu Provincial Drug Administration
Zhejiang Provincial Drug Administration Anhui Provincial Drug Administration
February 13, 2020
