News Update - 0901~0907

Department

Update

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CMDE

Notice on Publicly Soliciting Comments on Six Registration Review Guidelines Including the Guideline for Registration Review of Gamma Beam Stereotactic Radiotherapy Systems (Draft for Comment)

Abstract：

1.Guideline for Registration Review of Gamma Beam Stereotactic Radiotherapy Systems (Draft for Comment)

2.Guideline for Registration Review of Electronic Infusion Pumps (Draft for Comment)

3.Guideline for Registration Review of Implantable Cardiac Pacing Lead Wires (2026 Revised Edition) (Draft for Comment)

4.Guideline for Registration Review of Hemodynamic Monitoring Products (Draft for Comment)

5.Guideline for Registration Review of Medical Electron Linear Accelerators (Draft for Comment)

6.Guideline for Registration Review of Implantable Cardiac Pacemakers (2026 Revised Edition) (Draft for Comment)

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Notice on Holding the Public Welfare Training Course for the Promotion of Medical Device Clinical Evaluation Standards

Abstract：

1.Interpretation and Q&A of YY/T 0297—2026 General Requirements for Quality of Medical Device Clinical Trials

2.Interpretation and Q&A of YY/T 2000—2026 Real-World Data for Medical Devices — Terms and Definitions

3.Interpretation and Q&A of YY/T 1997—2026 Requirements for Biological Sample Management in Clinical Trials of In Vitro Diagnostic Reagents

4.Interpretation and Q&A of YY/T 1998—2026 General Requirements for Quality of Clinical Trials of In Vitro Diagnostic Reagents

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Notice on Holding the 89th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Interpretation of the Guideline for Registration Review of Ultrasonic Soft Tissue Surgical Equipment

2.Guideline for Registration Review of Quantitative Shear Wave Ultrasound Liver Measurement Devices

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Notice on Publicly Soliciting Comments on 59 Class II Active Medical Device Registration Review Guidelines Including the Guideline for Registration Review of Negative Pressure Suction Devices (Draft for Comment)

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Notice on Publicly Soliciting Comments on 16 Class II In Vitro Diagnostic Reagent Registration Review Guidelines Including the Guideline for Registration Review of Parathyroid Hormone Assay Reagents (Draft for Comment)

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Notice on Publicly Soliciting Comments on 55 Class II Passive Medical Device Registration Review Guidelines Including the Guideline for Registration Review of Radioactive Seed Implantation Protection Products (Draft for Comment)

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What studies are required when adding a single-tube single-test packaging specification to a multi-test large-pack PCR detection reagent?

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Clinical Trial Requirements for Human Immunodeficiency Virus Antibody Detection Reagents Using Fingerstick Blood Samples

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