Nine medical device companies: clinical trials were detected problems

Pharmaceutical Network December 29 hearing December 27, the State Food and Drug Administration released the "2017 second batch of medical equipment clinical trial supervision and spot checks of the situation (No. 163 of 2017)", a total of 9 companies in 9 Clinical trial of medical device registration project was identified, the full text is as follows:

In order to implement the "Regulations on the Supervision and Administration of Medical Devices" and implement the "State Council's policy on reform." drug (Guofa [2015] No.44) to further strengthen the supervision and administration of clinical trials of medical devices, the State Food and Drug Administration organized the first batch of submissions on the examination and approval of medical devices from October 23 to 29, 2017 Second batch of medical device registration application project clinical trial supervision and checking.About the inspection and processing results are announced as follows:

In the inspection, there are 9 registered application projects the following problems:

(A) Hui Ren Wangdu Medical Equipment Technology Co., Ltd. of the guided magnetic resonance imaging system (registration number: CQZ1600042) in Hebei Medical University second hospital , Third Hospital of Hebei Medical University to carry out clinical trials: unlicensed consent of non-clinical trial institutions outside the premises to conduct tests; non-clinical laboratory personnel involved in the operation of test equipment; clinical trial related image evaluation records incomplete.

(B) of Arnold (Beijing) Medical Technology Co., Ltd. of the intraocular lens (registration number: CQZ1600179) Capital Medical University in Beijing Tongren Hospital, People's Liberation Army Fourth Military Medical University Tangdu Hospital clinical trials carried out: individual The original records of case clinical trials did not record the reason and time of modification; the distribution and recovery records of control products were not provided; and the expiration date of some tested products was not recorded.

(C) Shaanxi Ruisheng Biotechnology Co., Ltd. guide tissue regeneration biofilm (registration number: CQZ1600334) Stomatological Hospital of the Fourth Military Medical University, Wuhan University, Stomatological Hospital to carry out clinical trials: ethics committee to save the program and registration application materials In the case of the number of cases and case distribution is inconsistent; case report form does not meet the requirements; "Medical Device Clinical Trial Notes" in the absence of technical indicators and other products tested.

(D) Liaoning Eui Arts and Technology Co., Ltd. drug-eluting balloon catheter (registration number: CQZ1700047) In Tianjin Chest Hospital, People's Armed Police Forces Hospital College Hospital clinical trials carried out: the original medical records Related records incomplete; individual subjects before enrollment did not complete the program required to complete the test; some of the data in the CRF table inconsistent with the original record.

(E) Epstein-barr virus nucleic acid quantitative detection kit (Fluorescent PCR method) (registration number: CQZ1700146) of Shanghai Fosun Changzheng Medical Science Co., Ltd. was carried out in Shanghai First People's Hospital and the Second Affiliated Hospital of Zhejiang University Medical School Of the clinical trials: informed consent for the fast trial, but did not provide the review members of the trial review; instrument transfer records did not retain the delivery number; clinical trial records are not accurate; statistical analysis of the report table did not make the removal of cases Description and so on.

(VI) Changzhou Xiruo Jia Medical Technology Co., Ltd. non-invasive combination of glucose meter (registration number: CQZ1700204) Changzhou First People's Hospital, Changzhou Second People's Hospital to carry out clinical trials: Ethics Committee approved the informed consent , CRF content and the implementation of informed consent, CRF content inconsistent; some clinical data and on-site statistical analysis of data inconsistency, etc. In addition, through on-site inspection and transfer of registration application information also found that the registration application before the start of clinical trials Did not submit the product type test report.

(VII) Shenzhen Hui Kang Precision Instrument Co., Ltd. shock wave therapeutic apparatus (registration number: CQZ1700393) in the First Affiliated Hospital of Xi'an Jiaotong University, Chengdu medicine University Hospital clinical trials carried out: Clinical trials related to incomplete records; individual cases did not record the combined medication; did not provide the test product distribution, recovery records.

(H) Purgo Biologies Inc. (proxy (Registration number: JQZ1700320) in the First Affiliated Hospital of Chinese People's Liberation Army General Hospital, People's Armed Police General Hospital conducted clinical trials: some incomplete clinical trial records; The relevant qualification documents of the control products were not provided; the statistical data of some laboratory test results of the total clinical trial reports in the total clinical trial reports and the registration application materials were inconsistent and so on.

(IX) D-dimer assay kit (Fluorescence Immuno-Dry Assay) by Boditech Med Inc. (Attorney: Bartlett (Qingdao) Biotech Co., Ltd.) (Registered Accession No .: JSZ1700013) In the People's Liberation Army No.36 Hospital, Xuzhou Central Hospital clinical trials carried out: did not provide clinical trials with the use of instruments, control of the transfer and testing records; remove the sample data based on inadequate; clinical trial control group test data without operator, review Signature confirmation and so on.

(A) of Changzhou Xiruo Medical Technology Co., Ltd. non-invasive combination of glucose meter registration application project in the conduct of clinical trials, in violation of the "medical instruments Clinical Trial Regulations "(formerly the State Food and Drug Administration Order No. 5) Article VI, in accordance with the" Medical Device Registration Regulations "(State Food and Drug Administration Order No. 4) Article 39 , Make a decision of not registering the application for registration, and instruct Jiangsu Food and Drug Administration to investigate and deal with the relevant units in accordance with the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices", and report the results of the processing to the SAO.

(B) of the remaining applications for registration, combined with the registration information and clinical trial supervision and inspection conducted a comprehensive analysis of the situation, in accordance with the relevant provisions of the review and approval.