NMPA Rejects or Terminates Registration of 59 Medical Devices in September (With List)
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NMPA announced that 11 medical devices were not registered in September, of which six were domestically produced and five were imported. The number of unregistered products this month increased by 37.5% compared to August. However, three cardiovascular and cerebrovascular products were not registered this time, including Heartflow's TAVR product.
Serial Number | Product Name | Applicant |
1 | Medical Ozone Therapy Device | Shaanxi Jinzheng Medical Technology Co., Ltd. |
2 | Pulmonary Artery Aspiration Catheter | Beijing Guanqiao Medical Technology Co., Ltd. |
3 | Peripheral Vascular Balloon Dilation Catheter | Hemu (China) Bioengineering Co., Ltd. |
4 | Transcatheter Aortic Valve System | Shanghai MicroPort CardioFlow Medtech Co., Ltd. |
5 | Absorbable Collagen Membrane | Xiling (Zhenjiang) Medical Technology Co., Ltd. |
6 | Dental Implant System | C-Tech Implant S.r.l |
7 | Sterile Disposable Protective Injection Device | SEPTODONT |
8 | Cone Beam Computed Tomography for Oral and Maxillofacial Region | Dentsply Sirona |
9 | Human SDC2/SFRP2/TFPI2 Gene Methylation Combined Detection Kit (Fluorescence PCR Method) | Suzhou Meihui Pharmaceutical Technology Co., Ltd. |
10 | X-ray Flat Panel Detector | THALES AVS FRANCE SAS |
11 | Temporary Crown and Bridge Resin Tempofit® Premium | DETAX GmbH |
NMPA News: In September, 48 medical devices ceased registration, including 31 domestically produced products and 17 imported products. This marks a 55% increase compared to the previous month, with imported products seeing a 2.8-fold increase from August. Multiple products from several companies in China collectively ceased registration, such as Taipu Bioscience (China) Co., Ltd. and Wondfo Biotech each having four products cease registration, while Hangzhou Broncus Medical Co., Ltd. had three products cease registration. Among the imported products, Johnson & Johnson and Smith&Nephew each had two products cease registration.
Serial Number | Product Name | Applicant |
1 | Pulmonary Function Instrument | MIR - Medical International Research S.p.A. |
2 | Coated Hip Joint Ball Head | China Aohui Technology Co., Ltd. |
3 | Hollow Bone Screw (Non-Locking) | Anhui Taikang Medical Technology Co., Ltd. |
4 | Cross-linked Sodium Hyaluronate Gel for Injection | PharmaResearch Co.,Ltd. |
5 | Precision Filter Infusion Set with Needle for Single Use | Shandong Aide Medical Products Co., Ltd. |
6 | Hepatitis B Virus Large Protein Detection Kit (Magnetic Particle Chemiluminescence Method) | Beijing Beller Biotechnology Engineering Co., Ltd. |
7 | Chlamydia Trachomatis/Neisseria Gonorrhoeae/Ureaplasma Urealyticum Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method) | Orian Biotechnology (Shanghai) Co., Ltd. |
8 | Medical Ozone Therapy Device | Humares GmbH |
9 | Decalcified Bone Matrix of the Same Species | Jiangxi Kesuo Biotechnology Co., Ltd. |
10 | Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescence PCR Method) | Zhejiang Orient Gene Biotech Co., Ltd. |
11 | Dental Adhesive | Kerr Corporation |
12 | Influenza A/B Virus and Respiratory Syncytial Virus Nucleic Acid Detection Kit (Fluorescence PCR Method) | Jiangsu Xunrui Biotechnology Co., Ltd. |
13 | Wound Debridement Hydrosurgery System | Smith&Nephew |
14 | Disposable Gas-Cooled Microwave Ablation Puncture Needle | Johnson & Johnson |
15 | 3D Planning Air-Cooled Microwave Ablation System | Johnson & Johnson |
16 | Methamphetamine, Ketamine, and MDMA Test Kit (Colloidal Gold Method) | Taipu Bioscience (China) Co., Ltd. |
17 | Methamphetamine and Ketamine Assay Kit (Colloidal Gold Method) | Taipu Bioscience (China) Co., Ltd. |
18 | Morphine and Methamphetamine Test Kit (Colloidal Gold Method) | Taipu Bioscience (China) Co., Ltd. |
19 | Amphetamine Test Kit (Colloidal Gold Method) | Taipu Bioscience (China) Co., Ltd. |
20 | Helicobacter pylori Antibody Detection Kit (Colloidal Gold Method) | Shenzhen Kangshengbao Biotechnology Co., Ltd. |
21 | Disposable Biopsy Needle | STERYLAB S.r.l. |
22 | Single-use Plasma Bilirubin Adsorber | Jafron Biotech Group Co., Ltd. |
23 | Ophthalmic Navigation Surgical Microscope | Carl Zeiss |
24 | Absorbable Polymer Coating Rapamycin-Eluting Coronary Stent System | Pulse Medical Technology Ireland Co., Ltd. |
25 | Ultrasonic High-Frequency Cutting and Hemostasis System | Weihai Weigao Dahe Surgical Energy System Co., Ltd. |
26 | Positron Emission and X-ray Computed Tomography System | Linyi Ruisi Medical Technology Co., Ltd. |
27 | Mycoplasma Pneumoniae IgG Antibody Detection Kit (Chemiluminescence Immunoassay) | Wondfo Biotech |
28 | Chlamydia Pneumoniae IgM Antibody Detection Kit (Chemiluminescence Immunoassay) | Wondfo Biotech |
29 | Mycoplasma Pneumoniae IgM Antibody Detection Kit (Chemiluminescence Immunoassay) | Wondfo Biotech |
30 | Chlamydia Pneumoniae IgG Antibody Detection Kit (Chemiluminescence Immunoassay) | Wondfo Biotech |
31 | Norovirus, Group A Rotavirus, Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR Method) | Cayundi Biotechnology (Yixing) Co., Ltd. |
32 | Debridement Water Jet System Disposable Handle | Smith&Nephew |
33 | Allogeneic Bone Repair Material | RuiboSi (Qingdao) Biotech Co., Ltd. |
34 | Disposable Venous Blood Collection Needle | Zhejiang Mainice Intelligent Diagnosis Technology Co., Ltd. |
35 | Sperm Cryopreservation Solution | Vitrolife Sweden AB |
36 | Absorbable Vascular Sealing Medical Adhesive | Saixkesai Biotech Co., Ltd. |
37 | Single-Use Bronchoscopic Thermal Vapor Therapy Catheter | Hangzhou Broncus Medical Co., Ltd. |
38 | Single-Use Pulmonary Radiofrequency Ablation Catheter | Hangzhou Broncus Medical Co., Ltd. |
39 | Human BRAF Gene V600E Mutation Detection Kit (Fluorescence PCR Method) | Suzhou Kebio Biotechnology Co., Ltd. |
40 | Rubella Virus IgM Antibody Quality Control Solution | Roche |
41 | Positive Pressure Needle-Free Infusion Three-Way Valve | Xi'an Ruopu Technology Co., Ltd. |
42 | Single-Use Bronchoscopic Thermal Vapor Ablation Catheter | Hangzhou Broncus Medical Co., Ltd |
43 | Teeth Whitening Gel | Starry Medical Health Technology (Nanjing) Co., Ltd. |
44 | Semiconductor Laser Therapy Device | Fengmai (Xiamen) Semiconductor Technology Co., Ltd. |
45 | Infrared Radio Frequency Therapy Device | Candela Corporation |
46 | Microcatheter | MicroVention |
47 | Absorbable Lacrimal Punctum Plug | Bio Optics Co., Ltd. |
48 | Vitreous Cutter Head | Bausch + Lomb |
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