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    Home > Active Ingredient News > Drugs Articles > 4 medical equipment registration applications are rejected! 51 enterprises withdraw 101 medical equipment registration applications

    4 medical equipment registration applications are rejected! 51 enterprises withdraw 101 medical equipment registration applications

    • Last Update: 2016-09-08
    • Source: Internet
    • Author: User
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    Source: on September 7, 2016, CFDA official website published the announcement on the supervision and spot check of clinical trials of four medical device registration application projects (No 147, 2016) According to the notice on the supervision and spot check of clinical trials of medical devices (2016) issued by the State Food and Drug Administration 1998), in July 2016, the General Administration organized the first batch of clinical trial supervision and spot check of medical devices Relevant information is as follows: test results (I) IgM / IgG antibody test kit for hepatitis E virus of Xiamen Bosheng Biotechnology Co., Ltd (colloidal gold method) (acceptance No.: quasi-15-1744) In the clinical trials carried out by the third people's Hospital of Liaoning Province, the clinical trial institutions could not provide the original records related to the trials; the trial samples were from our hospital and out of hospital respectively, and our samples could not be in hospital his Tracing in the system or diagnosis and treatment records, the samples outside the hospital have receiving records, but cannot be traced, some samples have no original records of preservation and use, and the samples have no original records of preservation and destruction; the information in the attachment "clinical trial data record form" of the clinical trial report submitted for registration and the "original data test record form" kept by the clinical trial institution The note information in is inconsistent In the clinical trials carried out by the Third Affiliated Hospital of Liaoning University of traditional Chinese medicine, the clinical trial institutions could not provide the original records related to the clinical trials; the samples could not be traced back, the sample numbering method could not be explained, and there was no original record in each link of sample preservation, use, preservation and destruction; the clinical trial scheme, report in the submitted registration application and the clinical trial institutions' preservation The protocol of the bed test and the signature and seal of the report are inconsistent; the relevant data in the attachment "clinical trial data record form" of the clinical trial report submitted for registration is inconsistent with the relevant data in the "original data test record form" kept by the clinical trial institution, for example, the sample numbers of more than 20 cases are different (2) The hepatitis B virus e antigen test kit (chemiluminescence method) (acceptance No.: quasi-15-2788) of Sichuan Mike Biotechnology Co., Ltd was used in the clinical trial carried out in the second West China Hospital of Sichuan University The clinical trial scheme stipulated that the test sample type was 350 Cases of serum, while the actual laboratory test sample type is plasma, the clinical test report sample type is serum (3) German orgentecdiagnosticka GmbH anti soluble liver antigen antibody test kit (enzyme immunoassay) (acceptance No.: Jin 15-1679), agent: Tianjin Xiupeng Biotechnology Development Co., Ltd In the clinical trial carried out by Tianjin People's Hospital, the clinical trial plan stipulates that the serum samples of the patients, which are routinely measured by the inspection department of the clinical trial institution, shall be randomly used, but the samples used in the clinical trial shall be provided by the applicant himself and cannot be traced back to the source (4) Bioland Co, Ltd.'s absorbable hemostatic collagen sponge (acceptance No.: Jin 15-2682), represented by Wuxi Huawei Pharmaceutical Co., Ltd in the clinical trial conducted by the Second Artillery General Hospital of the people's Liberation Army, the original course record showed that the subject with No 2090 was the 10th after operation Incision infection occurred in days, but the clinical trial report showed that all patients did not have postoperative infection, which was inconsistent with the actual situation Treatment decision (1) according to the provisions of Article 39 of the administrative measures for the registration of medical devices and Article 49 of the administrative measures for the registration of in vitro diagnostic reagents, the examination kit for IgM / IgG antibody of hepatitis E (colloidal gold method) of Xiamen Bosheng Biotechnology Co., Ltd (acceptance No.: quasi-15-1744) ), hepatitis B virus e antigen test kit (chemiluminescence method) (acceptance No.: quasi-15-2788) of Sichuan Mike Biotechnology Co., Ltd., anti soluble liver antigen antibody test kit (enzyme immunity method) (acceptance No.: jin-15-1679) of orgentecdiagnosticka GmbH, Germany and bioland Co., Ltd., South Korea, Four registration application items of absorbable hemostatic collagen sponge (acceptance No.: 15-2682) of Ltd will not be registered (2) According to Article 78 of the administrative license law of the people's Republic of China, the above-mentioned four registration applications shall not be accepted again within one year from the date of non registration (3) If the clinical trial institutions of the above four registration application projects are suspected of issuing false reports, the relevant provincial food and drug administration shall be ordered to investigate and deal with them in accordance with the relevant provisions of the regulations on the supervision and administration of medical devices, and report to the State Food and drug administration Other matters in October 2016, the State Food and Drug Administration will organize the second batch of clinical trial supervision and spot check of medical devices The registration applicant shall carefully self check the medical device registration application items under review and withdraw the existing problems After the State Food and Drug Administration announced the list of the second batch of medical device clinical trial supervision and spot check items in 2016, the application withdrawn by the registration applicant listed in the scope of supervision and spot check will not be accepted At the same time, the CFDA website also released the announcement on the announcement of 51 Enterprises withdrawing 101 medical device registration application projects (2016 No 146) As of August 25, 2016, a total of 51 Enterprises withdrawing 101 medical device registration application projects Withdrawal of medical device registration application list ■ source / CFDA official website
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