News Update - 251221-1227

Department

Update

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NMPA

Notice of the National Medical Products Administration on Issuing the Priority Review Catalog for High-End Medical Devices (2025 Edition) (No. 48 of 2025)

Abstract:

Effective as of the date of publication

Priority Review Product Catalog:

- Boron Neutron Capture Therapy Systems

- Ultra-High Field Magnetic Resonance Imaging Equipment (≥5T)

- Medical Electron Accelerators

- Implantable Brain-Computer Interface Medical Devices

- Endoscopic Surgical Control Systems

- Transcatheter Tricuspid Valve Replacement or Repair Systems

- Implantable Glaucoma Drainage Devices for Minimally Invasive Glaucoma Surgery (MIGS)

- Membrane Oxygenators (for ECMO)

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Announcement of the National Medical Products Administration on Issuing the Administrative Provisions for Medical Device Export Sales Certificates (No. 126 of 2025)

Abstract:

Effective May 1, 2026

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Announcement of the National Medical Products Administration on the Issuance of the Administrative Provisions on the Filing of Internet-Based Pharmaceutical and Medical Device Information Services (No. 123 of 2025)

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CMDE

Notice Regarding Arrangements for Pre-Submission Technical Consultation on Medical Device Registration Applications for January–February 2026 (No. 31, 2025)

Abstract:

Review Department VI, Clinical and Biostatistics Department II, Comprehensive Operations Department: January 9 / January 30 / February 27

Review Department I, Review Department II, Clinical and Biostatistics Department I: January 16 / February 6

Review Department III, Review Department IV, Review Department V: January 23 / February 13

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Public Notice of Review Results for Priority Review Applications of Medical Devices (No. 14, 2025)

Abstract:

Product Name: Fully Automated PCR Analysis System

Company Name: Shenzhen Shangliang Technology Co., Ltd.

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Notice Regarding the 57th Offline Training Session of the “Cloud Classroom for Device Review”

Abstract:

Guidance Principles for the Registration Review of Aspergillus Nucleic Acid Detection Reagents

Guidance Principles for the Technical Review of Cryptococcus Capsular Polysaccharide Antigen Detection Reagents

Clinical Trial Requirements  

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Public Notice of Review Results for Innovative Medical Device Special Review Applications (No. 13, 2025)

Abstract:

1. Product Name: Artificial Heart Valve

Company Name: Suzhou Xinling Maide Medical Technology Co., Ltd.

2. Product Name: Implantable Cardiac Defibrillator Lead

Company Name: Medtronic, Inc.

3. Product Name: Bone Adhesive Material

Company Name: Hangzhou Yuannang Biotechnology Co., Ltd.

4. Product Name: Absorbable Closure Clip and Applicator Forceps

Company Name: Dazhi Biomedical Technology (Jiangsu) Co., Ltd.

5. Product Name: Absorbable Coil

Company Name: Shentun Medical Technology (Shanghai) Co., Ltd.

6. Product Name: Tumor Tissue Origin Gene Detection Kit (Joint Probe-Anchored Polymerase Sequencing Method)

Company Name: Nanjing Shihuo Medical Devices Co., Ltd.

7. Product Name: Intraoperative Nerve Monitoring and Parathyroid Detection Device

Company Name: Beijing Turing Zhiyi Medical Technology Co., Ltd.

8. Product Name: Single-Use Intracranial Laser Balloon

Company Name: Hangzhou Juzheng Medical Technology Co., Ltd.

9. Product Name: Tumor Knee Prosthesis

Company Name: Beijing Lida Kang Technology Co., Ltd.

10. Product Name: Pulsed Ablation System and Single-Use Pulsed Ablation Catheter

Company Name: Ronghe Medical Technology (Zhejiang) Co., Ltd.

11. Product Name: Embolization Hydrogel

Company Name: Shanghai Ruining Biotechnology Co., Ltd.

12. Product Name: Self-Expanding Intra-Aneurysmal Embolization Device

Company Name: Tongqiao Medical Technology Co., Ltd.

13. Product Name: Pulmonary Radiofrequency Ablation System

Company Name: Hangzhou Kunbo Biotechnology Co., Ltd.

14. Product Name: Combined Detection Kit for Hepatocellular Carcinoma Multi-Gene Methylation, Alpha-Fetoprotein (AFP), AFP Isoform Ratio (AFP-L3%), and Abnormal Prothrombin (PIVKA-II)

Company Name: Hangzhou Aorui Gene Technology Co., Ltd.

15. Product Name: Interventional Left Ventricular Assist System

Company Name: Fengkeli Medical Devices (Shanghai) Co., Ltd.

16. Product Name: Absorbable Medical Adhesive

Company Name: Beijing Bio-Hui Rui Jin Biotechnology Co., Ltd.

17. Product Name: Single-Use Pressure Monitoring Pulsed Electromagnetic Ablation Catheter

Company Name: B. Braun Webster (Israel) Co., Ltd.

18. Product Name: Three-Branch Aortic Arch Stent System

Company Name: Xianjian Technology (Shenzhen) Co., Ltd.

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Notice on Adjusting Arrangements for Pre-Submission Technical Consultation on Medical Device Registration (No. 30, 2025)

Abstract:

Three Additional Regional Centers to Offer Pre-Submission Technical Consultations

National Center: Every Friday, 1:30 PM–4:30 PM

Yangtze River Delta Regional Center (Shanghai), Greater Bay Area Regional Center (Shenzhen), Beijing-Tianjin-Hebei Regional Center (Beijing), Central China Regional Center (Wuhan), Southwest Regional Center (Chongqing): Every Thursday, all day

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Infographic: Summary of Medical Device Technical Review Work in November 2025

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Can research data from the shelf life study of intraocular lenses with other optical designs be used to substitute for the research data of the declared product? What should be noted?

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