News Update - 0713~0719

Department

Update

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CMDE

Notice on Holding the 82nd Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Introduction to Review Requirements of the New Edition of GB 9706.1

2.Interpretation of the Guideline for Technical Review of Active Medical Device Service Life Registration

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Publicity of Review Results for Special Review Applications for Innovative Medical Devices (No. 12 of 2026)

Abstract：

1.Product Name: Disposable Intracranial Artery Imaging Catheter

Applicant: Shenzhen Mingsi Medical Technology Co., Ltd.

2.Product Name: Pancreaticojejunostomy Drainage Stent

Applicant: Hangzhou Saints Technology Co., Ltd.

3.Product Name: Coronary Covered Stent System

Applicant: Shanghai MicroPort Medical (Group) Co., Ltd.

4.Product Name: Implantable Left Ventricular Assist System

Applicant: Shenzhen Core Medical Technology Co., Ltd.

5.Product Name: Self-Expanding Intracranial Rapamycin-Eluting Stent System

Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.

6.Product Name: Implantable Hypoglossal Nerve Stimulation System

Applicant: Shanghai Shanling Medical Technology Co., Ltd.

7.Product Name: Cataract Treatment Device

Applicant: Zhejiang Boye Biotechnology Co., Ltd.

8.Product Name: Medical Electron Linear Accelerator

Applicant: Beijing Huake Xianfeng Medical Device Co., Ltd.

9.Product Name: Ultra-High Dose Rate Electron Radiation Therapy System

Applicant: Zhongjiu Flash Medical Technology Co., Ltd.

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Notice of the Center for Medical Device Evaluation, NMPA on Issuing the Guideline for Registration Review of Central Venous Catheters (2026 Revised Edition) (No. 23 of 2026)

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NIFDC

The National Institutes for Food and Drug Control Publicly Solicits Comments on the Instructions for Three National Standards and Reference Materials for In Vitro Diagnostic Reagents Used in Registration Testing

Abstract：

1.National Reference Material for Hepatitis C Virus Nucleic Acid Blood Screening Reagents

2.National Standard for 17α-Hydroxyprogesterone in Frozen Human Serum

3.National Reference Material for Epstein-Barr Virus Nucleic Acid Detection Reagents

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