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Department |
Update |
Link |
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NMPA |
Announcement on the Work Schedule for Pre-Acceptance Technical Consultation on Medical Device Registration for July–August 2026 (No. 373) |
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Announcement on the Abolishment of Certain Outdated and Invalid Documents (No. 372) |
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CMDE |
Notice of the Center for Medical Device Evaluation, NMPA on Issuing the Technical Review Key Points for Varicose Vein Closure Adhesive Products (No. 20 of 2026) |
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Notice on Soliciting Information from Relevant Enterprises and Institutions for Participating in the Development of the Guideline for Registration Review of Patient Positioning Systems for Radiotherapy |
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Notice on Publicly Soliciting Comments on Three Guidelines Including the Guideline for Registration Review of Clinical Evaluation of Artificial Intelligence-Assisted Diagnostic Medical Devices (Draft for Comment) |
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Publicity of Review Results for Priority Review Applications for Medical Devices (No. 14 of 2026) Abstract： Product Name: Extracorporeal Cardiopulmonary Support System
Applicant: Beijing Aerospace Changfeng Co., Ltd.
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Notice of the Center for Medical Device Evaluation, NMPA on Issuing the Technical Review Key Points for Tumor Gene Variation Detection Reagents (Trial) and Its Interpretation (No. 18 of 2026) |
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Notice of the Center for Medical Device Evaluation, NMPA on Issuing the Guideline for Registration Review of HLA-B58:01 Gene Detection Reagents (No. 17 of 2026) |
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Publicity of Review Results for Special Review Applications for Innovative Medical Devices (No. 10 of 2026) Abstract： 1.Product Name: Spinal Dura Mater Medical Adhesive Applicant: Success Bio-Tech Co., Ltd.
2.Product Name: Articular Cartilage Repair Scaffold Applicant: Yantai Dinghao Biotechnology Co., Ltd.
3.Product Name: Medical Electron Linear Accelerator Applicant: CNNC Particle Medical Technology Co., Ltd.
4.Product Name: Proton Therapy System Applicant: P-Cure Ltd.
5.Product Name: Implantable Vagus Nerve Stimulation System Applicant: Beijing Pins Medical Device Co., Ltd.
6.Product Name: Transcatheter Mitral Valve Clip System Applicant: Shanghai Push Medical Device Co., Ltd.
7.Product Name: Ocular Fundus Injection Surgery System Applicant: Beijing Tongmu Medical Device Co., Ltd.
8.Product Name: Biological Artificial Blood Vessel Applicant: Lingbo Biotechnology (Hangzhou) Co., Ltd.
9.Product Name: Implantable Brain-Computer Interface System for Hand Motor Function Compensation Applicant: Shanghai NeuroHu Technology Co., Ltd.
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Infographic – Summary of Medical Device Technical Review Work in May 2026 |
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