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NMPA: Ninety-Four Review Reports Released in 2022

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The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices.

Overseas manufacturers including Boston Scientific, Edwards Lifesciences, Uptake Medical, ViewRay, etc. are on the list. Some utilized the Hainan Real-World Data pathway for their national approval.

As the NMPA standardizes and streamlines the review process for fast-track approval, it is vital for manufacturers to comply with requirements of following items if you have similar equipment entering China market:

  1. Pre-clinical
  2. Clinical
  3. Risk-Benefit Analysis

Full List of NMPA Review Reports 2022

Below is the complete list of devices with review reports issued in 2022:

  • Endovascular ultrasound diagnostic equipment
  • Disposable endovascular ultrasound to diagnose catheter
  • Disposable pressure monitoring magnetically positioned radiofrequency ablation catheter
  • Artificial blood vessels
  • Hepatitis B virus RNA (HBV-RNA) assay kit
  • Drug-eluting coronary stent system
  • Left atrial appendage occluder system
  • Aspheric diffraction multifocal intraocular lenses
  • Peripheral blood cell images, leukocyte-assisted recognition software
  • Aspheric diffraction multifocal intraocular lenses
  • Mycobacterial identification kit
  • Septin9/SDC2/BCAT1 gene methylation assay kit
  • Tuberculosis X-ray image-assisted evaluation software
  • intracranial aneurysm flow diverter mesh stent
  • Antiembolic cerebral protection system
  • Patent ductus arteriosus occluder device
  • Intracranial aneurysm surgical planning software
  • Absorbable silk fibroin tissue-regeneration membrane
  • Bone Morphogenetic Protein (BMP) bone graft
  • Methylated Septin9/SDC2/BCAT1 DNA diagnostic Kit (PCR-Fluorescent Probe Method) (CSZ2000117).
  • Integrated membrane oxygenator
  • Proton therapy system
  • Biolimus A9 drug-coated balloon
  • Fundus imaging assisted diagnostic software for chronic glaucoma optic neuropathy
  • Magnetic resonance imaging system
  • Magnetic resonance guided radiation therapy system
  • Medical adhesives
  • Encephalitis/meningitis multi-pathogen nucleic acid combined detection kit (nested multiplexing of PCR melting curve assay).
  • Human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 methylated DNA assay kit (fluorescence PCR method).
  • Anastomoses reinforcement patch
  • absorbable oxidized regenerated cellulose hemostatic granules
  • Electronic colonoscopic imaging assisted polyps detection software
  • Single-use intravascular ultrasound diagnostic catheter
  • Endovascular ultrasound diagnostic instrument
  • ENT dual-source cone-beam computed tomography (CT) equipment
  • Genetic analysis software for tumor tissue origin
  • Implantable left ventricular assist device (LVAD) system
  • Gamma-beam stereotactic radiation therapy system
  • Tumor tissue origin gene detection kit (PCR fluorescent probe method).
  • Gene sequencer
  • prosthetic transcatheter pulmonary valve (TPV) system
  • Cryoablation equipment
  • Disposable cryoablation balloon catheter
  • Laparoscopic surgical system
  • Endoscopic Ultrasound (EUS) diagnostic equipment for gastrointestinal (GI) tract
  • Endodontic surgery dynamic navigation system
  • Magnetic resonance imaging system
  • Positron emission X-ray computed tomography system
  • Thoracic aortic stent system
  • Single-use endovascular imaging catheters
  • Endovascular imaging devices
  • Patient-programmed charger
  • Preimplantation chromosomal aneuploidy detection kit (semiconductor sequencing method)
  • Implantable leadless transcatheter pacing system
  • Human SFRP2 and SDC2 gene methylation combined detection kit (fluorescent PCR method).
  • Single-use peripheral intravascular shockwave catheter
  • Intravascular shockwave therapy equipment
  • Single-use coronary intravascular shockwave catheter
  • Six respiratory pathogens nucleic acid diagnostic kits (multiplex fluorescent PCR)
  • Nitric oxide therapy device
  • Spinal cord nerve stimulating test electrodes
  • Knee replacement surgery navigation and positioning system
  • Knee replacement surgery navigation and positioning system
  • Iliac vein stent system
  • Hip replacement surgery navigation and positioning system
  • Magnetic resonance imaging system
  • α and β Thalassemia Genetic diagnostic Kit (combined probe anchored polymerization sequencing).
  • Non-derivatized amino acids, carnitine, adenosine, lysolithin, and succinylacetone assay kit (tandem mass spectrometry)
  • Biological mesh for cardiac surgery
  • SDC2 and TFPI2 gene methylation joint detection kit (fluorescent PCR method).
  • Hot steam therapy equipment
  • Disposable transbroncho endoscopic hot steam therapy catheter
  • CT image aided triage software for intracranial hemorrhage
  • Ceftadime/avibactam concentration gradient agar diffusion sensitive strip (concentration gradient agar diffusion method).
  • Disposable prostate hot steam therapy device
  • Hot steam therapy equipment
  • Leukemia-related 15 fusion gene detection kit (fluorescent RT-PCR method).
  • Mobile head to neck magnetic resonance imaging system
  • Digestive tract vibrating capsule system
  • Stent positioning system
  • SHOX2/RASSF1A/PTGER4 Gene Methylation Diagnostic Test Kit (PCR-Fluorescent Probe Method)
  • Patient monitors
  • Helicobacter pylori 23S rRNA and gyrA diagnostic test kit for gene mutation (fluorescent PCR method)
  • Aldehyde ketone reductase 1B10 assay kit (time-resolved fluorescence immunoassay).
  • Radioactive seed implantation needle
  • Laparoscopic surgical system
  • Dual-channel implantable deep brain stimulation pulse generator kit
  • Implantable deep brain stimulation extension lead kit
  • Dual-channel rechargeable implantable deep brain stimulation (DBS) pulse generator kit
  • Implantable deep brain stimulation (DBS) electrode lead kit
  • Implantable spinal cord nerve stimulation extension lead
  • Neurosurgical navigation and positioning system
  • Implantable spinal cord nerve stimulation electrode

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