News Update - 0727~0803

Department

Update

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CMDE

Notice on Publicly Soliciting Comments on Matters Related to the Synchronous Development of Anti-tumor Drugs and Original Companion Diagnostic Reagents

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Notice on Publicly Soliciting Comments on the Technical Review Key Points for Clinical Trials of Implantable Brain-Computer Interface Systems for Hand Motor Function Compensation (Draft for Comment)

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Notice on Holding the 84th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Key Points for Pre-Market Evaluation of Single-Use High-Pressure Contrast Media Injectors and Accessories

2.Key Points for Review of Medical Needle-Free Injectors

3.Introduction to Technical Review Requirements for Single-Use Infusion Devices

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Publicity of Review Results for Priority Review Applications for Medical Devices (No. 16 of 2026)

Abstract：

Product Name: Glaucoma Drainage Device

Applicant: Glaukos Corporation

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NIFDC

Forwarded Notice of the Medical Device Packaging Standardization Technical Committee on Conducting the Survey on Implementation Evaluation of the Industry Standard YY/T 0681.15—2019 Test Methods for Sterile Medical Device Packaging — Part 15: Performance Testing of Shipping Containers and Systems

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Announcement of the National Medical Products Administration on Issuing the Amendments to Four Medical Device Industry Standards Including YY 0830—2011 Ultrasound Therapy Equipment for Superficial Tissue (No. 68 of 2026)

Abstract：

1.Amendment No. 1 to the Medical Device Industry Standard YY 0830—2011 Ultrasound Therapy Equipment for Superficial Tissue

2.Amendment No. 1 to the Medical Device Industry Standard YY/T 1120—2021 Dentistry — Operating Lights

3.Amendment No. 1 to the Medical Device Industry Standard YY/T 1737—2020 Analytical Methods for Bioburden Control Levels of Medical Devices

4.Amendment No. 1 to the Medical Device Industry Standard YY/T 1755—2021 Dentistry — Sandblasting Handpieces and Sandblasting Powders

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