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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