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NMPA Review Reports Released for Boston Scientific’s RWD Devices

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The NMPA published 33 review reports from January to April 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices.

Overseas manufacturers including Boston Scientific, Edwards Lifesciences and Uptake Medical are on the list. Among them, Boston Scientific gained two approvals, Rezūm Water Vapor Therapy equipment and disposable prostate treatment accessory, utilizing Hainan Real-World Data clinical pathway.

It only took four months for Boston Scientific from submitting the registration application to guaranteeing approval. Allergan’s glaucoma drainage system, and J&J’s femtosecond laser eye treatment system used the same pathway to get national approvals in 2021.

Complete List NMPA Review Report 2022

Below is the list of review reports issued in 2022. If you have similar devices entering China market, please contact us at info@ChinaMedDevice.com.

  • Spinal cord nerve stimulation 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
  • Alpha and Beta Thalassemia gene detection kit (Combined probe-anchored polymerization sequencing)
  • Non-derivatized amino acid, carnitine, adenosine, lysolecithin and succinylacetone assay kit (tandem mass spectrometry)
  • SDC2 and TFPI2 gene methylation combined detection kit (fluorescence PCR method)
  • Hot steam therapy equipment
  • Disposable transbronchial endoscopic hot vapor therapy catheter
  • CT image-assisted triage software for intracranial hemorrhage
  • Ceftazidime/Avibactam concentration gradient agar diffusion sensitivity strip (concentration gradient agar diffusion method)
  • Hot steam therapy equipment
  • Disposable prostate hot steam treatment device
  • Mobile head and neck MRI system
  • 15 fusion gene detection kits related to leukemia
  • Digestive tract vibrating capsule system
  • Bracket positioning system
  • SHOX2/RASSF1A/PTGER4 gene methylation detection kit (PCR-fluorescent probe method)
  • patient monitor
  • Aldehyde and ketone reductase 1B10 assay kit (time-resolved fluorescence immunoassay)
  • Helicobacter pylori 23S rRNA gene and gyrA gene mutation detection kit (fluorescent PCR method)
  • Special puncture needle for radioactive seed implantation
  • Laparoscopic surgery system
  • Dual channel implantable deep brain stimulation pulse generator kit
  • Implantable deep brain stimulation electrode lead kit
  • Dual channel rechargeable implantable deep brain stimulation pulse generator kit
  • Implantable deep brain stimulation extension lead kit
  • Neurosurgery navigation and positioning system
  • Implantable spinal nerve stimulation extension lead