Innovative Medical Devices Special Review Application Examination Results Public Notice (No. 13 of 2025)

According to the National Medical Products Administration's "Special Review Procedure for Innovative Medical Devices" (Announcement No. 83 of 2018 by the National Medical Products Administration), the Office for the Review of Innovative Medical Devices has organized relevant experts to review applications for special review. The following application projects are proposed to enter the special review process and are now being publicly announced. The announcement period is from December 24, 2025, to January 8, 2026.

1. Product Name: Artificial Heart Valve

Applicant: HearHill

2. Product Name: Implantable Cardioverter Defibrillator Lead

Applicant: Medtronic plc

3. Product Name: Bone Adhesive Material

Applicant: Hangzhou Origo Biotechnology Co., Ltd.

4. Product Name: Absorbable Closure Clip and Applier

Applicant: Daci Biomedical Technology (Jiangsu) Co., Ltd.

5. Product Name: Absorbable Coil

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

6. Product Name: Tumor Tissue Origin Gene Detection Kit (Combined Probe Anchored Polymerization Sequencing Method)

Applicant: Nanjing Shihew Medical Device Co., Ltd.

7. Product Name: Intraoperative Neuromonitoring and Parathyroid Detector

Applicant: Beijing Turing Zhiyi Medical Technology Co., Ltd.

8. Product Name: Disposable Intracranial Laser Balloon

Applicant: Hangzhou Juzheng Medical Technology Co., Ltd.

9. Product Name: Tumor Knee Joint Prosthesis

Applicant: Beijing LeadCare Technology Co., Ltd.

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

Applicant: Ronghe Medical Technology (Zhejiang) Co., Ltd.

11. Product Name: Embolic Hydrogel

Applicant: Shanghai Rui Ning Biotechnology Co., Ltd.

12. Product Name: Self-Expanding Intracranial Aneurysm Occluder

Applicant: Tongqiao Medical Technology Co., Ltd.

13. Product Name: Pulmonary Radiofrequency Ablation System

Applicant: Hangzhou堃博Biotechnology Co., Ltd.

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

Applicant: Hangzhou Aorui Gene Technology Co., Ltd.

15. Product Name: Interventional Left Ventricular Assist System

Applicant: Fengkaili Medical Devices (Shanghai) Co., Ltd.

16. Product Name: Absorbable Medical Adhesive

Applicant: Beijing Bohui Ruijin Biotechnology Co., Ltd.

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

Applicant: Biosense Webster (Israel) Limited Liability Company

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

Applicant: Lifetech Scientific (Shenzhen) Co., Ltd.

During the public announcement period, if any organization or individual has objections, they may submit their opinions in writing and send them to our center's email address: gcdivision@cmde.org.cn.

Special Note:Entering the innovative review process does not mean that the product has been deemed to possess the safety and efficacy required for registration approval. The applicant is still required to carry out research and development and submit a registration application in accordance with relevant requirements. Drug regulatory authorities and related technical institutions will conduct evaluation and approval based on the principles of early intervention, designated personnel responsibility, and scientific review, under the premise that standards are not lowered and procedures are not reduced.

ComeSource: Center for Medical Device Evaluation, National Medical Products Administration

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