News Update - 0606~0612

Department

Update

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NMPA

The General Department of the National Medical Products Administration is soliciting public comments on the “Guidance Principles for Inspections of Medical Device Quality Management Systems (Draft for Comment)”

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CMDE

Notice on Soliciting Public Comments on 11 Technical Review Guidelines, Including the “Technical Review Guidelines for Deep Learning-Based Dynamic ECG Analysis Software (Draft for Comment)”

Abstract:

1. Technical Review Guidelines for Deep Learning-Based Dynamic ECG Analysis Software

2. Technical Review Guidelines for Inflatable External Counterpulsation Devices

3. Technical Review Guidelines for Radioactive Seed Implantation Needles

4. Technical Review Guidelines for Single-Use High-Frequency Tissue Grasping Forceps

5. Technical Review Guidelines for Intravascular Infusion Catheters

6. Technical Review Guidelines for Absorbable Facial Implant Threads

7. Technical Review Guidelines for Clinical Evaluation of Fixation Pins Used with HA-Coated External Fixation Frames

8. Technical Review Guidelines for Clinical Evaluation of All-Suture Anchors Within the Same Product Class

9. Technical Review Guidelines for Clinical Trials of Transcatheter Tricuspid Valve Replacement and Repair Systems

10. Technical Review Guidelines for Clinical Decision-Making Regarding Transcatheter Aortic Valve Systems

11. Technical Review Guidelines for Clinical Trial Data of Human Urothelial Carcinoma Gene Methylation Detection Kits

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Notice on Soliciting Public Comments on the “Guidance Principles for the Registration Review of Infant Radiant Warming Tables (Draft for Comment)”

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Notice on Soliciting Public Comments on the “Guidance Principles for the Registration Review of Infant Incubators (Draft for Comment)”

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CDR-ADR

Notice on Soliciting Public Comments on the “Glossary of Medical Device Adverse Event Terminology (Draft for Comment)”

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