News Update-260104~0110

Department

Update

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NMPA

Public Notice of the General Office of the National Medical Products Administration on the Project Approval of 2 Recommended Medical Device Industry Standards Including Reliability Verification Methods for Invasive Medical Devices Adopting Brain-Computer Interface Technology

Abstract：

Reliability Verification Methods for Invasive Medical Devices Adopting Brain-Computer Interface Technology

Paradigm Design and Application Specifications for Medical Devices Adopting Brain-Computer Interface Technology—Motor Function Reconstruction

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Announcement of the National Medical Products Administration on Adjusting Some Contents of the Classification Catalogue of Medical Devices (No. 132 of 2025)）

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Recall Information

Abstract：

1.Edwards: Acumen IQ Finger Cuff

2.Maquet: Heater-Cooler Unit

3.Boston: SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System

4.Philips: Picture Archiving and Communication System (PACS)

5.Elekta: Oncology Information System (OIS)

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CMDE

Public Notice on the Review Results of Priority Approval Applications for Medical Devices (No. 1 of 2026)

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Company Name: Jiangsu Kayo Biotechnology Co., Ltd.

Product Name: Human DAB2IP, CHFR, GRASP Gene Methylation Combined Detection Kit (PCR-Fluorescent Probe Method)

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Announcement of the Center for Medical Device Evaluation of the National Medical Products Administration on Issuing the Guidelines for the Registration Review of Human Leukocyte Antigen (HLA) Genotyping Detection Reagents (No. 2 of 2026)

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Announcement of the Center for Medical Device Evaluation of the National Medical Products Administration on Issuing the Guidelines for the Registration Review of Endotracheal Intubation Products (2026 Revised Edition) (No. 1 of 2026)

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Notice on Holding the 59th Offline Tutorial Session of "Device Evaluation Cloud Classroom"

Abstract：

1.Discussion on Key Points for the Evaluation of Artificial Intelligence Functions in Diagnostic Ultrasound

2.Interpretation of the Guidelines for Registration Review of Ultrasound Soft Tissue Surgical Devices

3.Guidelines for Registration Review of Quantitative Shear Wave Ultrasound Liver Measurement Systems

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Public Notice on the Review Results of Special Review Applications for Innovative Medical Devices (No. 1 of 2026)

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1.Product Name: Shock Wave Valve Therapy System

Applicant: Zhiweixin Medical Technology (Changzhou) Co., Ltd.

2.Product Name: Magnetic Resonance Imaging System

Applicant: GE Healthcare Systems (Tianjin) Co., Ltd.

3.Product Name: Self-Expanding Thoracolumbar Spinal Fixation System

Applicant: Shandong Weigao Orthopaedic Materials Co., Ltd.

4.Product Name: Human Special Blood Group Genotyping Detection Kit (Microfluidic Chip Method)

Applicant: Henan Landsteiner Gene Technology Co., Ltd.

5.Product Name: Implantable Left Ventricular Assist System

Applicant: Shanghai Huanqing Medical Technology Co., Ltd.

6.Product Name: Insulin Pump

Applicant: Suzhou Hechun Medical Technology Co., Ltd.

7.Product Name: Absorbable Drug-Eluting Peripheral Stent System

Applicant: Yuanxin Technology (Shenzhen) Co., Ltd.

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NIFDC

Call for Standard Project Proposals for 2026

Abstract：

Field of Medical Infusion Devices

Field of Dental Equipment and Instruments

Medical Protective Devices

Biological Evaluation of Medical Devices

ISO/TC 194 International Standards

ISO/TC 76 International Standards

Medical Device Packaging

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Notice of the General Office of the National Institutes for Food and Drug Control on Soliciting Drafting and Verification Entities for the 2026 National Standard Formulation and Revision Projects of Artificial Intelligence Medical Devices

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Hong Kong

The Department of Health implements new regulations to enhance the procurement of medical devices.

Abstract：

Enhanced measures under the new Phase C regulations will take effect on March 23, 2026, further raising requirements such that applicable medical devices procured must be listed medical devices.

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