The General Administration issued a notice on the supervision and spot checks of clinical trials of four medical device registration applications

On September 6, 2016, the State Administration of Food and Drug Administration issued an announcement on the monitoring and spot checks of the first batch of medical device clinical trials in 2016. Upon examination, Xiamen Bosheng Biotechnology Co., Ltd.'s hepatitis E virus IgM/IgG anti-medical test kit (colloidal gold method) (acceptance number: quasi-15-1744), Sichuan Mike Biotech Co., Ltd.'s hepatitis B virus e antigen determination kit (chemical luminescence method) (acceptance number: quasi-15-2788), Germany ORORECDiagnostikaGmbH anti-soluble hepatitis anti-soluble hepatic anti-antigen The four registered application items of the kit (Enzyme Immunology Method) (receiving number: in 15-1679) and Bioland Co., Ltd., Ltd., which can absorb hemoglobin sponge (receiving number: in 15-2682), have the authenticity of clinical trial institutions not being able to provide the original records related to the trial, clinical samples used in clinical trials provided by the applicant themselves and not traceable, clinical trial reports inconsistent with on-site inspection findings.
In accordance with the relevant provisions on medical device registration, the State Food and Drug Administration shall not register the above four registration applications with authenticity problems, shall not accept them again within one year from the date of non-registration, and shall charge the relevant provincial and municipal food and drug regulatory agencies with investigating and handling them in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices. (State Administration of Food and Drug Administration)