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NMPA: Thirty Guidelines Issued in July

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The NMPA published 30 guidelines in July 2023, to guide manufacturers for local type testing, pre-clinical, clinical studies, and regulatory submissions.

For English copies of any guidelines below, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

  • Key review points for ultrasound imaging artificial intelligence software (process optimization) Read our comprehensive article
  • Key review points for performance valuation on artificial intelligence analysis software for pathological images
  • Key review points for clinical evaluation on artificial intelligence analysis software for pathological images
  • Key review points for performance evaluation on artificial intelligence analysis software for blood disease flow cytometry
  • Key Review Points for Animal testing of extracorporeal membrane oxygenation (ECMO) consumable products
  • Clinical evaluation guideline on predicate comparison of ventilators
  • Guideline on continuous glucose monitoring system
    View our comprehensive article
  • Guideline on blood thawing device
  • Guideline on respiratory humidifier
  • Guideline on intestinal hydrotherapy machine
  • Guideline on molecular sieve oxygen generator
  • Guideline on bladder ultrasound scanner
  • Guideline on single-use peritoneal dialysis catheters
  • Guideline on respiratory filters
  • Guideline on oropharyngeal/nasopharyngeal airway
  • Guideline on liquid dressings
  • Guideline on gel dressings
  • Guideline on β-hydroxybutyric acid detection reagent
  • Guideline on methotrexate detection reagent
  • Guideline on anti-cyclic citrullinated peptide antibody detection reagent
  • Guideline on Gram-positive bacteria identification reagent
  • Guideline on transcatheter aortic valve system
  • Guideline on vascular intervention devices with lubricating coatings
  • Guideline on non-vascular self-expanding metal stent system
  • Guideline on medical device product benefits – risk determination
  • Guideline on extracorporeal membrane oxygenation (ECMO) temperature control equipment
  • Guideline on mobile ECG atrial fibrillation testing products
  • Guideline on insulin pumps
  • Guideline on high-flow respiratory therapy equipment
  • Clinical evaluation guideline on predicate comparison of hip prostheses

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