News Update - 0619~0701

Department

Update

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NMPA

Lei Ping Investigates the Innovative Development of Brain-Computer Interface Medical Devices in Shanghai

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Notice of the National Medical Products Administration on Issuing Two Medical Device Guidelines Including the Guideline for Classification and Definition of Brain-Computer Interface Medical Device Products and the Guideline for Generic Naming of Brain-Computer Interface Medical Devices (No. 24 of 2026)

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Interpretation of the Guideline for Generic Naming of Brain-Computer Interface Medical Devices

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Interpretation of the Guideline for Classification and Definition of Brain-Computer Interface Medical Device Products

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CMDE

Publicity of Review Results for Special Review Applications for Innovative Medical Devices (No. 11 of 2026)

Abstract：

1.Product Name: Artificial Blood Vessel

Applicant: Jiangxi Keweitai Biotechnology Co., Ltd.

2.Product Name: Ophthalmic Surgery Assistance System

Applicant: Guangzhou Weimou Medical Device Co., Ltd.

3.Product Name: Digestive System DNA Fragment Signature Detection Kit (Combined Probe-Anchor Polymerization Sequencing Method)

Applicant: Nanjing Shihe Medical Device Co., Ltd.

4.Product Name: Puncture Surgery Navigation and Positioning System

Applicant: Beijing Yirujingzhi Medical Technology Co., Ltd.

5.Product Name: Abdominal Aortic Stent Graft System

Applicant: Lombard Medical Ltd.

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Notice on Publicly Soliciting Comments on the Guideline for Registration Review of Clinical Evaluation of Dental Restorative Materials for Implant Prosthetics — Same-Variety Comparison (Draft for Comment)

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Notice on Holding the 79th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Introduction to Technical Review Key Points for Additive Manufactured Passive Orthopedic Implants

2.Introduction to Technical Review Focus Points for Additive Manufactured Intervertebral Fusion Cages

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Medical Device Priority Review Application Review Result Publication (No. 15 of 2026)

Abstrsct：

Product Name: Chikungunya Virus & Dengue Virus Nucleic Acid Detection Kit (Fluorescent PCR Method)

Applicant: Coyote Bioscience Yixing Co., Ltd.

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Notice of the Center for Medical Device Evaluation, NMPA on Issuing the Guideline for Registration Review of Medical Magnetic Resonance Imaging Systems (2026 Revised Edition) (No. 21 of 2026)

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SAC

A Number of National Standards to Take Effect on July 1

Abstract：

Medical Electrical Equipment — Part 2-66: Particular Requirements for the Basic Safety and Essential Performance of Hearing Aids and Hearing Aid Systems, GB/T 9706.266—2025

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NIFDC

Notice on Publicly Soliciting Comments on Partial Adjustments to the Medical Device Classification Catalogue

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Summary of the First Batch of Medical Device Product Classification Determination Results in 2026

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