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China Medical Device Standards Management Annual Report (2023)
2024-05-11
In 2023, China NMPA approved and issued 117 industry standard projects for medical devices, which were divided into formulation projects (57, 48.7%) and revision projects (60, 51.3%) according to the formulation and revision of standards.
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IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method) Approved for Marketing
2024-02-06
Recently, the application for registration of innovative product "IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method)" of ShenZhen Sciarray Biotechnology Co., Ltd. was approved by China NMPA.
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Reagents for Detection of Influenza A Viruses Approved by China NMPA
2024-02-01
So far, China NMPA has approved a total of 66 reagents for detection of influenza A viruses, including 23 antigen detection products, 5 antibody detection products, and 38 nucleic acid detection products.
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Gastric Bypass Stent System Approved for Marketing
2024-01-17
Recently, the innovative product "Gastric Bypass Stent System" of Hangzhou Tongee Medical Technology Co., Ltd. was approved by China NMPA.
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Robot-Assisted Fracture Reduction System for Pelvic Fracture Approved for Marketing
2023-12-11
Recently, the innovative product Robot-Assisted Fracture Reduction System for Pelvic Fracture of Beijing Rossum Robot Technology Co., Ltd. is approved by China NMPA.
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Gelatin Polycaprolactone Layered Gingival Repair Membrane Approved for Marketing
2023-11-30
Recently, the innovative product Gelatin Polycaprolactone Layered Gingival Repair Membrane of Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. is approved by China NMPA.
