On May 14, 2018, Shanghai Municipal Food and Drug Administration (SMFDA) issued the Notice of Shanghai Municipal Food and Drug Administration on Issuing the First Batch of Supervising and Spot-checking Items of Medical Devices for Clinical Trials of 2018. Six items will be supervised and checked on site, with the details as follows:
In order to implement the Regulation on the Supervision and Administration of Medical Devices, Norms on the Quality Management for the Clinical Trials of Medical Devices, (Order No. 25, CFDA) and further strengthen supervision and management of clinical trials for medical devices of Shanghai, SMFDA selected 4 registration application items, including rechargeable attachable dynamic ECG system (Acceptance Number: 17-070, 17-135, 18-X001, and 18-030) and 2 clinical trial items, including renal artery RF ablation catheter (Clinical Record Number: HYLB 20170039, and 20170216). The authenticity and compliance of the clinical trial data for these items will be inspected and checked on site. The acceptance number (clinical record number), product name, applicant and undertaker of clinical trial for specific registration application items are shown in the attachment. The specific inspection schedule and names of clinical trial institutions to be checked are subject to further notice by the SMFDA.
The first batch of items to be supervised and checked in 2018 (names of companies): Ensense Biomedical Technologies (Shanghai) Co., Ltd.; Shanghai Fosun Long March Medical Science Co., Ltd.; Shanghai United Imaging Medical Technology Co., Ltd. (2 products); Shanghai Tracing Biotech Co., Ltd.; Shanghai Huida Medical Devices Co., Ltd.
In order to implement the Regulation on the Supervision and Administration of Medical Devices, Norms on the Quality Management for the Clinical Trials of Medical Devices, (Order No. 25, CFDA) and further strengthen supervision and management of clinical trials for medical devices of Shanghai, SMFDA selected 4 registration application items, including rechargeable attachable dynamic ECG system (Acceptance Number: 17-070, 17-135, 18-X001, and 18-030) and 2 clinical trial items, including renal artery RF ablation catheter (Clinical Record Number: HYLB 20170039, and 20170216). The authenticity and compliance of the clinical trial data for these items will be inspected and checked on site. The acceptance number (clinical record number), product name, applicant and undertaker of clinical trial for specific registration application items are shown in the attachment. The specific inspection schedule and names of clinical trial institutions to be checked are subject to further notice by the SMFDA.
The first batch of items to be supervised and checked in 2018 (names of companies): Ensense Biomedical Technologies (Shanghai) Co., Ltd.; Shanghai Fosun Long March Medical Science Co., Ltd.; Shanghai United Imaging Medical Technology Co., Ltd. (2 products); Shanghai Tracing Biotech Co., Ltd.; Shanghai Huida Medical Devices Co., Ltd.