NMPA On Issuing Relevant Technical Guidelines In December 2021

In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, according to the Administrative Measures for Registration and Filing of Medical Devices (Order No. 47 of the NMPA), NMPA has organized and formulated relevant technical guidelines.

Below is the summary of NMPA guidelines in December 2021:

• Guidelines for technical review of clinical evaluation with predicate for ultrasonic soft tissue dissection hemostasis system
• Guidelines for registration review and clinical evaluation with predicate for oral implant surgical navigation and positioning system
• Guidelines for registration review of microwave ablation equipment
• Guidelines for registration review of endoscopic surgical power tools
• Guidelines for registration review of clinical trials for non original CDx companion diagnostic reagents of antitumor drugs
• Guidelines for registration review of overseas clinical trial data using in vitro diagnostic reagents
• Guidelines for registration review of arthroscopic passive surgical instruments
• Guidelines for registration review of disposable ureteral access sheath
• Guidelines for orthodontic wire registration review
• Guidelines for registration review of disposable minimally invasive fascia closure device
• Guidelines for registration review of anesthesia mask products
• Guidelines for registration review of non vascular lumen guidewire products
• Guidelines for registration review of circumcision stapler
• Guidelines for registration review of dental desensitizer
• Guidelines for registration review of extracorporeal membrane oxygenation (ECMO) circulation package
• Guidelines for registration review of disposable abdominal puncture device
• Guidelines for registration review of ossicular prostheses
• Guidelines for registration review of artificial ligament
• Guidelines for product registration review of funnel chest forming system
• Guidelines for registration review of fluorescence immunochromatography analyzer
• Guidelines for registration review of network atomizer
• Guidelines for registration review of medical diagnostic X-ray equipment including pediatric applications
• Guidelines for registration review of ultrasound transcranial Doppler System for blood-flow measurement
• Guidelines for registration review of hydrogen peroxide sterilizer
• Guidelines for registration review of newborn blue light phototherapy system
• Guidelines for registration review of root canal preparation machine
• Guidelines for registration review of hematology analyzer
• Guidelines for registration review of gait training equipment
• Guidelines for registration review of pepsinogen I / II testing reagents
• Guidelines for registration review of prothrombin time / activated partial thromboplastin time / thrombin time / fibrinogen test reagent product  
• Guidelines for registration review of retinol binding protein assay kit (immunoturbidimetry)
• Guidelines for registration review of folic acid determination reagents
• Guidelines for registration review of anti Mullerian hormone assay reagents

Please refer to the above guidelines. If you need help on medical device registration in China, please feel free to contact us (info@inspirativemed.com) for any questions.