News Update-0201~0207

Department

Update

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CMDE

Registration Review Guidelines for Sodium Hyaluronate-Based Injectable Filler Agents for Plastic Surgery and Cosmetic Procedures

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The 63rd "Equipment Inspection Cloud Classroom" Offline Tutoring Class

Abstract:

X-ray image guidance system for radiotherapy

Single photon emission X-ray computed tomography system

Energy spectrum imaging technology of X-ray computed tomography equipment

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Notice on Soliciting Opinions on the "Catalogue of Third-Class Medical Devices Subject to Clinical Trial Approval (Revised Edition 2026) (Draft for Comment)"

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Special Review Result Announcement for Innovative Medical Devices (No. 3, 2026)

Abstract:

1. Product Name: Software for Assisting in the Evaluation of Chronic Obstructive Pulmonary Disease

Applicant: Bojiang Life Sciences (Shanghai) Co., Ltd.

2. Product Name: Ultrasound Therapy Device

Applicant: Shenzhen Tengfu Medical Technology Co., Ltd.

3. Product Name: Transcatheter Artificial Tricuspid Valve

Applicant: Edwards Life Sciences LLC

4. Product Name: Transcatheter Artificial Tricuspid Valve

Applicant: Jiangsu Zhenyi Medical Technology Co., Ltd.

5. Product Name: Ultrasound Thrombolysis Catheter and Stent System

Applicant: Shanghai Tengfu Medical Technology Co., Ltd.

6. Product Name: Radiation Therapy Planning Software

Applicant: Guokeshion Ion Medical Technology Co., Ltd.

7. Product Name: Implantable Cardiac Rhythm Regulator and Defibrillator

Applicant: Chuangling Cardiac Rhythm Management Medical Devices (Shanghai) Co., Ltd.

8. Product Name: Peripheral Balloon Covered Stent System

Applicant: Zhejiang Guichong Medical Technology Co., Ltd.

9. Product Name: Thoracoabdominal Endoscopic Surgical System

Applicant: Visual Medical Company

10. Product Name: Coronary Sinus Balloon Counterpulsation System

Applicant: Shanghai Minxian Lingyu Medical Technology Co., Ltd.

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