CFDA Released 9 Technical Review Guidelines

China’s State Council: Official Opinions On Deepening the Review and Approval Policies Reform and Encouraging Drug And Medical Device Innovations
November 7, 2017
CFDA Released a New Notice about “The Related Work for Regulating the Medical Device Classification.”
November 17, 2017

CFDA Released 9 Technical Review Guidelines

On September 28th, CMDE issued 4 medical device technical review guidelines for comments

1.     Drug Eluting Coronary Stent System Preclinical Study Technical Review Guideline.

2.     Mobile Medical Device Registration Technical Review Guideline

3.     Ophthalmic femtosecond laser treatment device registration technical review guidelines

4.     Continuous glucose monitoring system technical review guideline

 

On October 9th, CFDA issued 5 registration technical review guidelines:

1.     Microplate Reader Registration Technical Review Guideline

Class II with class code 6840-3

2.     Disposable ECG Electrode Registration Technical Review Guideline

Class II with class code 6821

3.     Dynamic Blood Pressure Meter Registration Technical Review Guideline

Class code 6821-13

4.     ECG Registration Technical Review Guideline (2017 Revised Version)

Class II with class code 6821

5.     Patient Monitoring Products (Class II) Registration Technical Review Guideline

Class II with class code 6821

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