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 classifications.
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
- Subcutaneous electronic syringe control booster
- RF skin hyperthermia
- Ultrasonic RF cavitation slimming device
- Eye skin hyperthermia
- Skin hyperthermia
- Ultrasonic skin treatment equipment
- Ultrasonic electrical stimulation device
- Electrotherapy 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.