NMPA (CFDA) published the First Batch
of Medical Device Classification Results on July 18. This document, classifying
Class III (56 items), Class II (78 items), Class I (53 items) and Non-Medical
Devices (5 items), serves as a guide to manufacturers for ambiguous device
Some cosmetic devices are classified as medical equipment for the first time. Previously cataloged as Non-Medical Device in 2014, ultrasonic skin treatment equipment, ultrasonic electrical stimulation device and electrotherapy ultrasound therapy device are now designated as Class II devices.
China Med Device helps
manufacturers identify NMPA classifications and registration units. Correct
classification will potentially save months of delay through the registration
process in China. info@ChinaMedDevice.com.
Below is the complete list of new
classifications for cosmetic devices:
- Absorbable pull
wire for plastic surgery
electronic syringe control booster
- RF skin
- Ultrasonic RF
cavitation slimming device
- Eye skin
- Skin hyperthermia
- Ultrasonic skin
electrical stimulation device
ultrasound therapy device
- Intense pulse
light skin treatment instrument
The Classification Results also
involves devices in anesthesiology, cardiovascular, dental, gastroenterology
and urology, obstetrical and gynecological, ophthalmic, orthopedic, pathology and molecular diagnostics.
For our comments on Medical Device Classification Catalog, please click HERE.
For NMPA link of First Batch of Medical Device Classification Results, please email info@ChinaMedDevice.com.
To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.