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CMDE

Publicity of Review Results for Priority Review Applications for Medical Devices (No. 18 of 2026)

Abstract：

Product Name: Disposable Membrane Oxygenator Kit

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Notice on Holding the 88th Session of the "CMDE Cloud Classroom" Offline Training Course

Abstract：

1.Interpretation of the Guideline for Registration Review of Contrast Injection Equipment

2.Interpretation of the Guideline for Registration Review of Beam Scanning Measurement Equipment

3.Interpretation of the Guideline for Registration Review of Positron Emission Magnetic Resonance Imaging Systems

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Publicity of Review Results for Special Review Applications for Innovative Medical Devices (No. 14 of 2026)

Abstract：

1.Product Name: Disposable Steep Pulse Ablation Electrode Needle

Applicant: Hunan Ewidi Medical Device Co., Ltd.

2.Product Name: Aortic Root Patch

Applicant: Beijing Bairen Medical Technology Co., Ltd.

3.Product Name: Aortic Valve Replacement System

Applicant: Shenzhen Jianxin Medical Technology Co., Ltd.

4.Product Name: Boron Neutron Capture Therapy System

Applicant: Huaboron Neutron Technology (Hangzhou) Co., Ltd.

5.Product Name: Biodegradable Left Atrial Appendage Occluder

Applicant: Shanghai Shape Memory Alloy Co., Ltd.

6.Product Name: Artificial Corneal Endothelial Lamellar Graft

Applicant: Aiyan Medical Co., Ltd.

7.Product Name: Implantable Brain-Computer Interface Neurostimulator

Applicant: Beijing Pins Medical Device Co., Ltd.

8.Product Name: Implantable Tibial Nerve Stimulation System

Applicant: Hangzhou Shenluo Medical Technology Co., Ltd.

9.Product Name: Human Circulating Tumor Molecular Residual Disease Detection Kit (Combined Probe-Anchor Polymerization Sequencing Method)

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

10.Product Name: Focused Ultrasound Neuromodulation Device

Applicant: Chongqing Haifu Technology Co., Ltd.

11.Product Name: Absorbable Dural Sealant

Applicant: Shandong Junxiu Biotechnology Co., Ltd.

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Publicity of Review Results for Priority Review Applications for Medical Devices (No. 17 of 2026)

Abstract：

1.Product Name: Unconjugated Bilirubin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry Method)

Applicant: Shenzhen Huiyun Biotechnology Co., Ltd.

2.Product Name: Claudin18.2 (EPR19202) Antibody Reagent (Immunohistochemistry Method)

Applicant: Guangzhou Anbiping Pharmaceutical Technology Co., Ltd.

3.Product Name: Leber Hereditary Optic Neuropathy Gene Detection Kit (PCR-Fluorescence Probe Method)

Applicant: Wenzhou Puxi Gene Technology Co., Ltd.

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If a polyurethane foam dressing product fails to meet some performance indicators of the standard YY/T 1293.2 due to special reasons, what aspects of documentation need to be submitted?

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NIFDC

The National Standard Artificial Intelligence Medical Devices — Quality Requirements and Evaluation — Part 1: Terminology Has Been Officially Issued

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Forwarded Notice on Conducting the Implementation Evaluation of Mandatory National Standards GB 9706.216—2021 and GB 9706.239—2021

Abstract：

The 2026 medical device standard implementation evaluation is hereby conducted for the following two standards: GB 9706.216—2021 Medical Electrical Equipment — Part 2-16: Particular Requirements for the Basic Safety and Essential Performance of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment and GB 9706.239—2021 Medical Electrical Equipment — Part 2-39: Particular Requirements for the Basic Safety and Essential Performance of Peritoneal Dialysis Equipment.

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Forwarded Notice on Conducting the Implementation Evaluation of the Mandatory National Standard GB 9706.260—2020

Abstract：

The 2026 medical device standard implementation evaluation is hereby conducted for GB 9706.260—2020 Medical Electrical Equipment — Part 2-60: Particular Requirements for the Basic Safety and Essential Performance of Dental Equipment.

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Notice of the Office of the National Institutes for Food and Drug Control on Conducting the 2026 Implementation Evaluation of Standards Under the Jurisdiction of the Medical Device Standardization Technical Committee for Human Assisted Reproductive Technology

Abstract：

The implementation evaluation is hereby conducted for YY/T 1688—2021 Medical Devices for Human Assisted Reproductive Technology — Methods for Staining and Counting Blastocyst Cells (implementation date: April 1, 2022).

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Notice of the Office of the National Institutes for Food and Drug Control on Conducting the 2026 Implementation Evaluation of Standards Under the Jurisdiction of the Medical Device Standardization Technical Committee for Medical Additive Manufacturing Technology

Abstract：

The implementation evaluation is hereby conducted for YY/T 1910—2023 Medical-Grade Beta-Tricalcium Phosphate Powder for Additive Manufacturing (implementation date: September 15, 2024).

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YRDCMDEI

Notice on Holding the 88th Session of the "CMDE Cloud Classroom" Offline Training Course (Yangtze River Delta Sub-Venue)

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