On May 17,2017, the CFDA issued a draft notice that the third batch of clinical trial exempt products for class II and class III devices have been added to the clinical trial exempt catalogue.
To further standardize the clinical evaluation of medical equipment, and increase the scope of the clinical trial exempt medical devices directory, CFDA organized and drafted the 3rd batch of clinical trials exempt list for feedback. There are 22 class II products and 6 class III products added to the clinical trial exempt list in the 3rd batch. See below for the list of products types. If you need clarification on the devices, please contact us.
China Med Device specializing in providing turn-key solution for medtech companies, brings you up to date information on CFDA. If you have any feedback, please e-mail to info@chinameddevice.com before June 20, 2017.
6 Class III products:
With titanium plate
Orthopedic screws
Fill the stick
Acetabular cups
Medullary plug
Needleless connector
22 Class II products:
Head nail
Spinal surgery tools
Spinal endoscopic surgical instruments
Arthroscopic endoscopic surgical instruments
Medical intervertebral foramen surgery
Surgical instruments for intervertebral discs
Infant skull orthopedic fixator
Uterine manipulator
Pen-type insulin syringe
Ophthalmic Surgical Microscope
Electronic endoscopic image processor
Endoscopic surgical planer
Ultrasonic bone density meter
Ultrasound treatment tips
Dental needle (non-metallic)
Orthodontic support with drilling
Correction of the holder
Dental hydrofluoric acid etchant
Temporary crown bridge material
Desensitizer
Dental cutting alloy
Uterine positioning handle