Hepatitis C Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)_NMPA Approval in April 2018
The Hepatitis C Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method), a domestic Class III innovative product approved by the NMPA in April 2018, is designed for the in vitro quantitative detection of HCV RNA in serum samples. The kit employs magnetic bead extraction and real-time fluorescent quantitative PCR technology using TaqMan probes. Through extensive research on production processes, reaction systems, and analytical performance, the applicant determined the optimal conditions for the kit, ensuring that its analytical performance met the required standards. Clinical trials conducted at three institutions demonstrated excellent performance and clinical equivalence to a marketed product, with a positive agreement rate of 99.1%, a negative agreement rate of 100.0%, and a total agreement rate of 99.2%, making it a reliable tool for the quantitative detection of HCV RNA in serum samples.
Read MoreVascular Reconstruction Device_NMPA Approval in March 2018
The Vascular Reconstruction Device is a Class III medical device designed for treating unruptured intracranial aneurysms. Extensive research, including technical analysis, biocompatibility assessments, animal experiments, and clinical trials, has validated its efficacy and safety. Results from studies, including significant differences in aneurysm occlusion rates and positive clinical outcomes, support the device's effectiveness in altering aneurysm hemodynamics and achieving treatment goals. The device demonstrates promise as an innovative and reliable solution for addressing intracranial aneurysms, highlighting its potential for improving patient outcomes and safety.
Read MoreRubella Virus IgG Antibody Test Kit (Fluorescent Immunochromatographic Assay)_NMPA Approval in February 2018
The Rubella Virus IgG Antibody Test Kit (Fluorescent Immunochromatographic Assay) underwent a thorough evaluation process and received NMPA approval in February 2018. This diagnostic kit is designed for the qualitative detection of rubella virus IgG antibodies in human serum or plasma, serving as an auxiliary diagnostic tool for rubella virus infection. The product's structure includes a rubella virus IgG antibody test card, ID chip, centrifuge tube, and buffer solution. Through extensive research on production processes, analytical performance, stability, and clinical evaluation, the kit demonstrated reliable and consistent results, showcasing its effectiveness in diagnosing rubella virus infections.
Read MoreMeasles Virus IgG Antibody Test Kit (Fluorescent Immunochromatographic Assay)_NMPA Approval in February 2018
The Measles Virus IgG Antibody Test Kit, a domestically classified Class III product, underwent thorough research and evaluation to assess its analytical performance, stability, and clinical efficacy. Comprising a test card, ID chip, centrifuge tube, and buffer solution, the kit is designed for qualitative detection of measles virus IgG antibodies in human serum or plasma. Extensive studies on production processes, reaction systems, and analytical performance were conducted, demonstrating conformity with reference materials, specificity, accuracy, and precision. The kit's stability under various conditions, including real-time storage and accelerated stability tests, was confirmed, ensuring reliable performance over time. Clinical trials conducted across multiple institutions validated the kit's performance, showing high concordance rates with comparator reagents and consistent results across different sample types. The study concludes that the Measles Virus IgG Antibody Test Kit is a reliable diagnostic tool for measles virus infection, meeting quality and performance standards for clinical use.
Read MoreAbsorbable Dural Sealant Medical Adhesive_NMPA Approval in January 2018
The product "Absorbable Dural Sealant Medical Adhesive" underwent comprehensive research and testing to validate its effectiveness and safety. The adhesive is composed of powder, two solutions, and complementary tools. It is designed to seal dural suture sites during craniotomy to prevent cerebrospinal fluid leakage. The main components undergo a reaction to form a hydrogel, providing adhesive action. Research included chemical structure analysis, in vitro degradation studies, and metabolic kinetics research. Biocompatibility evaluation and sterilization confirmation were conducted, ensuring safety and sterility. Animal studies demonstrated the product's efficacy and safety. Clinical trials showed a 100% immediate sealing effectiveness during surgery, surpassing the target value of 94%. Postoperative assessments revealed minimal adverse events, highlighting the product's safety profile.
Read MoreHuman EGFR Mutation Gene Detection Kit (Multiplex Fluorescent PCR Method)_NMPA Approval in January 2018
The Human EGFR Mutation Gene Detection Kit is a Class III product designed for qualitative detection of EGFR mutations in plasma DNA samples from advanced NSCLC patients. The kit utilizes ARMS and fluorescence PCR technology to detect specific mutations like 19 exon deletion, L858R, and T790M. Analytical studies confirmed its low detection limit, precision, specificity, and stability under various conditions. Clinical evaluations showcased its effectiveness in guiding treatment decisions for NSCLC patients, particularly in selecting EGFR-TKI drugs like osimertinib tablets (Tagrisso) and erlotinib hydrochloride tablets (Iressa). Overall, the kit demonstrates reliable performance and clinical utility in personalized treatment selection for NSCLC patients.
Read MoreGene Sequencer_NMPA Approval in December 2017
The Gene Sequencer, a China's domestic Class III medical device, was approved by the NMPA in December 2017 and utilizes combinatorial probe anchor synthesis sequencing technology for analyzing DNA samples in clinical settings. The BGISEQ-50 model employs DNA nanoballs and cPAS sequencing core technology to ensure accurate signal processing. It meets safety requirements and undergoes performance research, including sample validation and mutation detection. The product has a service life of 7 years, validated through accelerated aging tests, while the software follows risk-based version naming rules. Clinical evaluation, based on the BGISEQ-500 model, includes data analysis from trials and usage, aligning with industry standards and guidelines for comprehensive assessment.
Read MoreDrug Eluting Balloon Catheter_NMPA Approval in December 2017
The Drug Eluting Balloon Catheter is a Class III medical device approved by the NMPA in December 2017 for dilating primary coronary artery bifurcation stenosis. It consists of a balloon coated with paclitaxel and iohexol for localized drug delivery to inhibit intimal proliferation. The product underwent performance research, biocompatibility testing, and sterilization validation. Animal experiments and clinical trials demonstrated its safety and efficacy, showing significant differences in postoperative 270-day stenosis compared to a control group. To further assess real-world effectiveness, post-market studies are recommended to monitor long-term safety and outcomes beyond the initial clinical trials.
Read MoreImplantable Pacemaker_NMPA Approval in November 2017
The Implantable Pacemaker, registered under the innovation pathway as a Domestic Class III product in 2017, is designed for the treatment of chronic arrhythmias. Comprising an implantable pulse generator and accessories, including a torque wrench, this device operates by detecting the heart's electrical activity through electrodes on implanted leads, catering to both dual-chamber and single-chamber configurations. It adheres to GB16174.1-1996 and YY/T 0491-2004 standards, showcasing performance indicators like pacing pulse frequency and sensitivity, alongside comprehensive protections against environmental impacts and unintended actions. Biocompatibility assessments per GB/T 16886 standards, ethylene oxide sterilization, and an 18-month shelf life validated through aging tests ensure safety and efficacy. Notably, canine model experiments have confirmed the device's performance, supported by software safety at Class C level and clinical evaluations comparing it with similar, marketed products.
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