News Update - 0804~0810

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CMDE

Publicity of Review Results for Special Review Applications for Innovative Medical Devices (No. 13 of 2026)

Abstract：

1.Product Name: Human Tumor Molecular Residual Disease Detection Kit (High-Throughput Sequencing Method)

Applicant: Guangzhou Burning Rock Medical Laboratory Co., Ltd.

2.Product Name: Glaucoma Drainage Tube

Applicant: Chengdu Migosi Medical Technology Co., Ltd.

3.Product Name: Transcatheter Mitral Valve Replacement System

Applicant: Shanghai MicroPort CardioFlow Medical Technology Co., Ltd.

4.Product Name: Biodegradable Magnesium Embolic Microspheres

Applicant: Chongqing Baimai Tengshi Pharmaceutical Technology Co., Ltd.

5.Product Name: Tumor Treating Fields Therapy Device

Applicant: Kunlun Zhiding (Beijing) Medical Technology Co., Ltd.

6.Product Name: General Anesthesia Infusion Pump System

Applicant: Shanghai Ruiyiwei Medical Technology Co., Ltd.

7.Product Name: Transurethral Implantable Prostate Staple

Applicant: Shanghai Lixiao Medical Technology Co., Ltd.

8.Product Name: Brucella Antibody Detection Kit (Microcolumn Gel Method)

Applicant: Zhuhai Langyue Biotechnology Co., Ltd.

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Notice on Holding the 85th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Introduction to Technical Review Key Points for Extracorporeal Circulation Products

2.Guideline for Technical Review of Clinical Evaluation for Registration of Centrifugal Blood Component Separation Equipment

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NIFDC

Forwarded Notice on Convening the Validation Meeting for Eight National Standards and National Standard Guiding Technical Documents Including Antimicrobial Susceptibility Testing — Technical Specification for Establishment of Antimicrobial Breakpoints — Part 1: General Requirements

Abstract：

1.20256732-Z-464 Medical Laboratories and In Vitro Diagnostic Systems — Liquid Chromatography-Mass Spectrometry Detection Methods — Part 1: General Requirements

2.20256729-Z-464 Raw Materials for In Vitro Diagnostic Reagents — Quality Evaluation Methods for Enzymes Used in Nucleic Acid Detection

3.20256730-Z-464 Raw Materials for In Vitro Diagnostic Reagents — Quality Evaluation Methods for Antibodies

4.20256731-Z-464 Raw Materials for In Vitro Diagnostic Reagents — Quality Evaluation Methods for Latex Particles

5.20251759-T-464 Antimicrobial Susceptibility Testing — Technical Specification for Establishment of Antimicrobial Breakpoints — Part 1: General Requirements

6.20251729-T-464 Antimicrobial Susceptibility Testing — Technical Specification for Establishment of Antimicrobial Breakpoints — Part 2: Methods for Determining Epidemiological Cutoff Values (ECOFF)

7.20251728-T-464 Antimicrobial Susceptibility Testing — Technical Specification for Establishment of Antimicrobial Breakpoints — Part 3: Methods for Determining Pharmacokinetic/Pharmacodynamic (PK/PD) Cutoff Values

8.20251760-T-464 Medical Laboratories and In Vitro Diagnostic Systems — Technical Specification for Detection of Special Antimicrobial Resistance in Bacteria and Fungi

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