Hereby announce. 2018 the first batch of medical devices clinical trial supervision and spot inspection report

Medical Network September 13 September 12, the State administration of Drug Administration announced the first batch of medical device clinical trial supervision and spot checks in 2018, through on-site inspection found 9 Registration Application project Clinical trials there is a compliance problem.
The original announcement is as follows:
In order to implement the regulations on supervision and administration of medical devices, the Executive Office of the Central Committee of the CPC Drug The opinion of medical Device innovation (Hall character (2017)42), strengthen the supervision and management of clinical trials of medical devices, the state Drug Administration organized the first batch of medical device registration application project in 2018 to supervise and spot-check in clinical trials from July 4, 2018 to 8th. The relevant inspection, the processing of comments and the relevant requirements are hereby announced as follows:
One, check the situation
The following compliance issues were identified in clinical trials of 9 registration application projects through on-site inspections:
(a) Shenyang Shangxian Medical System Co., Ltd. Capsule endoscope System (Registration number: CQZ1700095) in the PLA Shenyang Military Region, the general Hospital And the clinical trial carried out by Yan Chai Hospital affiliated to Shanghai Jiaotong University Medical College: The use of the product is not recorded in the registration form; Failure to provide transportation, storage conditions and distribution records for the product under test; The case report form has been modified, but the amendment has not been signed and confirmed. (b) The thoracic Aortic Stent System (Registration No.: CQZ1700331) of Beijing Hua Mai Medical Instrument Co., Ltd. in the clinical trials conducted by the PLA General Hospital and Ningxia Medical University: The main curative effect evaluation of individual subjects was not carried out according to the clinical trial program; Incomplete data were recorded in the case report form of some subjects;
Some of the combined medications in individual case reports are not reflected in the statistical report. (c) The absorbable hemostatic membrane of Beijing Great Qing Biotechnology Co., Ltd. (Registration No.: CQZ1700366) in the clinical trials carried out in Tianjin People's Hospital and Jinan City Center Hospital: The records of the use of the trial products were not reflected in the medical records of individual subjects and in the surgical record sheets;
Individual subjects were not eligible for entry Standard ; The omission of adverse events of individual subjects; The training records of some clinical trial researchers were not provided. (iv) Guangzhou Hong Sing Biological Technology Co., Ltd. Single-use bilirubin adsorption column (registration number: CQZ1700411) in the Foshan first People's Hospital and Guangzhou People's Hospital in the clinical trial: the ethical approval does not indicate the clinical trial program and informed consent version number; No reasonable reasons for the family to sign an informed consent letter; Deviations from clinical trial protocols are not documented;
The leakage of adverse events of individual subjects was recorded. (e) Tianjin and Jie Medical Equipment Co., Ltd. One-time use of drug-containing cervical expansion stick (registration number: CQZ1700545) in the third Hospital of Peking University and Tianjin Medical University General Hospital to carry out clinical trials: some of the subjects were outpatient surgery, but did not save the operation record sheet; The trial products in the clinical trial report had no original record in the detaining time of the cervical orifice.
In some records, the names of the tested products are inconsistent. (vi) Nanjing Zhen Tai Microwave Technology Co., Ltd. Multi-frequency Microwave Acupuncture Physiotherapy Instrument (registration number: CQZ1800127) in the Jiangsu Provincial Hospital and Jiangsu Province integrated Traditional Chinese Medicine hospital in the clinical trial: informed consent to the lack of risk-informed content; No record of the use and management of the tested product is provided; No participants were provided with the treatment record card;
The clinical trial program saved by the clinical trial organization is not stamped and so on. (vii) The Medical Electronic Linear Accelerator (Registration No.: CQZ1800167) in the first hospital of Jilin University and the Zhongshan Hospital affiliated to Dalian University: The researchers determined that the serious adverse events unrelated to the product were not recorded in the clinical trial report;
Some subjects had no pathological diagnosis, and did not meet the requirements of clinical trial program.
(eight) Medtronic, Inc. 's drug-coated peripheral balloon dilatation Catheter (registration number: JQZ1700507) (Agent Person: Medtronic (Shanghai) Management Co., Ltd.) in the clinical trials of the affiliated Gulou Hospital of Nanjing University Medical College and the first affiliated Hospital of Fujian Medical University: The central laboratory did not analyze the results of imaging examinations with poor efficacy and had no reasonable reasons; The main curative effect index in the test operation manual is inconsistent with the actual calculation formula. (ix) Siemens Healthcare Diagnostics Products Limited thyroid stimulating hormone receptor antibody assay kit (Chemiluminescence method) (registration number: JSZ1700099) (Agent: Siemens Medical Diagnostics (Shanghai) Co., Ltd.) In the clinical trial conducted by the Peking Union Hospital of Chinese Academy of Medical Sciences and the second hospital of Tianjin Medical University, the regulations of the clinical trial organization are inconsistent with those of the clinical trial program;
There were no previous medical records in 10 patients with pre-treatment diagnosis, and 12 subjects had no pre-treatment diagnosis or medical records.
Ii. handling of comments and related requirements
(a) The above 9 registration application projects, combined with registration information and clinical trial supervision and inspection of the comprehensive analysis, in accordance with the relevant provisions for review and approval.
Two Medical devices Clinical trial sponsors, clinical trial institutions and researchers to strengthen learning and strict implementation of the "Medical device clinical trial Quality management norms" to ensure that the clinical trial process of scientific norms, the results are true and reliable.
(c) The provincial drug regulatory departments should attach great importance to taking effective measures to strengthen the supervision of clinical trials of medical devices in their respective administrative areas.
Hereby announce. 2018 the first batch of medical devices clinical trial supervision and spot inspection report