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| The first batch of clinical trial supervision of medical devices has been published. There are three projects that have real problems |
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| Author：中国铭铉 企划部 Release Time：2017-9-6 15:45:23 Number Browse：821 |
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Medical network - on September 6, on September 5, the state food and drug supervision and administration bureau's website has released the first batch of medical instrument clinical trial supervision and spot check, check found three registration project authenticity problems in clinical trials.
Learned, according to the implementation of supervision and spot check medical instrument clinical trial in 2017 notice "requirement, July 23, 2017-30, the state food and drug supervision and management of administration organization to carry out the first batch of medical instrument clinical trial supervision and spot checks.
Its examination results show:
(a) 252Cf neutron post-installation treatment system in shenzhen city of californium pretech co., LTD
In the third military medical university third hospital (ohtsubo hospital) in clinical trials, the scene only after 252 cf neutron treatment of radiation treatment planning system, institutions can not provide radiation treatment of original records, nor after 252 cf neutron treatment system source data; No record of the use of the 252Cf neutron post-installation treatment system.
Clinical trials conducted in north guangdong guangdong people's hospital, clinical trials for registered products with products useful - 1000 type 252 cf neutron after treatment system, declaration and registration data of clinical test plan and test report of products for ZK - type A after 252 cf neutron treatment system; Registered clinical trial version) filings (Version3.1) and content (, treatment methods and the results of all criteria evaluation method) and the clinical test units saved version (1.0 and Version3.1) and content, and in the process of clinical trials, 30 cases of patients according to version 1.0 plan execution, version 3.1 scheme in accordance with the 16 cases of subjects.
(2) xuzhou Asia Pacific technology co., LTD. 's cardiovascular expansion balloon catheter
In shenyang military area command of the Chinese people's liberation army general hospital and children's hospital affiliated to chongqing medical university to conduct clinical trials, clinical institutions saved can be traced back 12 months follow-up cases of postoperative follow-up and clinical trial registration filing data summary report do not match the number of cases.
(3) helicobacter pylori saliva test kit of the diagnostic reagent (jiaxing) co., LTD. (colloidal gold method)
In shaanxi university of traditional Chinese medicine affiliated hospital to carry out clinical trials, some participants did not look up to the test during digestion second branch (test) department in attendance record () registration information, outpatient medical history, clinical diagnosis, unable to verify the actual circumstances of the subjects to participate in clinical trials; Subjects in addition, the inspection of clinical diagnosis of TCM diagnosis, clinical trial registration filing report of clinical diagnosis of western medicine in the diagnosis of clinical trial data record, 253 subjects to western medicine diagnosis based on support.
For this, the CFDA has made the following decision:
(a) according to the prescribed in article 39 of the "measures for the administration of medical device registration" and "registration measures for the management of in vitro diagnostic reagent" article 49, of californium pury technology co., LTD in shenzhen after 252 cf neutron treatment system (acceptance number: CQZ1600204), Asia Pacific technology co., LTD. Cardiovascular expansion of xuzhou balloon catheter (acceptance number: CQZ1600519) diagnostic reagents and litai lattice (jiaxing) co., LTD., h. pylori saliva detection kit (colloidal gold) (accepted number: CSZ1600257) three registration project will not be registered.
(2) according to article 78 of the administrative licensing law of the People's Republic of China, the above-mentioned three registration application items shall not be accepted again within one year from the date of non-registration.
(3) an application for registration of the above three items of clinical trials on suspicion of false report issued by the clinical test units and the relevant responsible persons, instruct the relevant provincial food and drug administration in accordance with the relevant provisions of the regulations on the supervision and administration of medical devices to investigate, and report to the administration of state food and drug supervision and administration of the processing results.
It is worth noting that in October 2017, the state food and drug supervision and administration bureau will be organized to carry out the second batch of medical instrument clinical trial selectives examination, registration applicant in the trial of medical device registration items shall be carefully check list, the inspection found problems can take the initiative to withdraw.
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