Department

Update

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CMDE

Public Notice on the Review Results of Special Review Applications for Innovative Medical Devices (No. 8 of 2026)

1. Product Name: CT Plain Scan Image-Assisted Diagnosis Software for Acute Aortic Syndrome

Applicant: Alibaba DAMO Academy (Beijing) Technology Co., Ltd.

2. Product Name: Magnetic Resonance Imaging-Assisted Diagnosis Software for Brain Tumors

Applicant: Fuming (Shanghai) Medical Technology Co., Ltd.

3. Product Name: Biodegradable Magnesium Metal Bone Fixation Screw

Applicant: Suzhou Zhuochai Medical Technology Co., Ltd.

4. Product Name: Microsurgery Control System

Applicant: Guangzhou Deep Medical Technology Co., Ltd.

5. Product Name: Tuberculosis Mycobacterium Rifampicin, Isoniazid, Fluoroquinolone Resistance Gene Mutation Detection Kit (Combined Probe Anchored Polymerase Sequencing Method)

Applicant: Nanjing Di Fei Medical Devices Co., Ltd.

6. Product Name: Visible Liquid Embolic Agent

Applicant: Zhiyuan Baimei (Zhejiang) Technology Co., Ltd.

7. Product Name: Anti-Thrombosis Brain Protection Device

Applicant: Ruishou (Shanghai) Medical Technology Co., Ltd.

8. Product Name: Heparin-Coated Artificial Blood Vessel

Applicant: Shengna Technology (Shanghai) Co., Ltd.

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CMDE

Notice on Soliciting Opinions on the "Registration Review Guidance Principles for Anastomosis Reinforcement Sutures (Draft for Comment)"

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CMDE

Draft of guidelines for public consultation:

1. Absorbable ligation clips

2. Breast rotary cutting puncture needles and accessories

3. One-time use cardioplegia fluid perfusion device

4. Plasma separator and plasma component separator

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