In order to further strengthen the clinical trial results and improve the quality of registration and approval of the second type of medical devices, the Shandong Provincial Bureau, in conjunction with the reform of the drug medical device review and approval system, issued the Notice on the Verification of the Authenticity Verification of the Second Class of Medical Devices. Part of the province has initiated the verification of the authenticity of clinical trials of some medical devices in trial.
The Shandong Provincial Bureau has clearly stated in the Notice that there are mainly four types of products included in the scope of this verification. One is the new product that has not been approved in Shandong Province, the second is the first registered product declared by the registered applicant, the third is the therapeutic equipment, and the fourth is the in vitro diagnostic reagent. In addition to the spot check on the clinical trials of in vitro diagnostic reagents, all other three types of products under review must be fully covered. The main contents of the verification include whether the clinical trial plan, report, and ethics committee's approval are true, whether it is consistent with the archived data of the clinical trial institution, and whether the number of original trials of clinical trial products is consistent with the test report. Because the in vitro diagnostic reagents have many registered products and clinical trial methods are similar, the Shandong Provincial Bureau stipulates that the same enterprise conducts clinical trials of more than 10 products in the same clinical trial institution, and 20% should be selected for verification. In other cases, two products are selected for verification.
It is understood that in the relevant policies for the registration and approval of medical devices, there is no verification link for the authenticity of clinical trials. The Shandong Provincial Bureau exploratoryly puts this work within 30 working days after the acceptance of the product registration application, and is certified by the provincial bureau. The center is responsible for organizing and implementing, and the verification of the registration quality management system is carried out in the same period. After the implementation of the “Quality Management Standard for Medical Device Clinical Trials†on June 1, 2016, it will be organized and implemented according to the verification standards and procedures formulated by the State Administration of Taxation. For the units that have found serious problems in the authenticity of clinical trials, the Shandong Provincial Bureau has clearly stated that it must be dealt with seriously according to relevant regulations and make public announcements.
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