CFDA added more class II and class III devices to the clinical trial exempt list

CFDA Updates 2017.05.02-2017.05.12
May 17, 2017
CFDA Update: Actions Taken to Deepen Registration Reform
May 25, 2017

CFDA added more class II and class III devices to the clinical trial exempt list

On May 17,2017CFDA 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