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