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Two Review Reports for Imported Devices Issued in January

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NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices.

These published review reports serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review the relevant ones for our clients’ specific products to gain more clarity and be more efficient in their submission and approval process.

Full List

  • Implantable deep brain stimulation directional lead (Medtronic)
  • Carbon PEEK composite plate system (CarboFix Orthopedics)
  • Human APOE genotyping assay kit
  • Disposable intracoronary shockwave catheter
  • Human CYP2D6 genotyping detection kit (PCR-fluorescent probe method)
  • Human FMR1 gene detection kit (fluorescence PCR-capillary electrophoresis)
  • Intravascular shock wave therapy equipment
  • Gastric bypass stent system
  • Human exosome CA125, HE4, C5a detection kit (chemiluminescence method)
  • Absorbable bone wax
  • Personalized abutment crown and bridge
  • Human ONECUT2/VIM gene methylation detection kit (fluorescence PCR method)

For an English copy of any review report above, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.

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