67 Innovative Medical Devices Granted Entry into China's Special Review Pathway: Prospectus Overview
Healinno Tech
Developer and Manufacturer of Surgical Robots and Intelligent Diagnostic and Therapeutic Equipment
Intervastec
Medical Device Manufacturer and Distributor
HearHill
Cardiovascular Innovation Product Developer
GenLight
Innovative Medical Device Solution Provider
3N Tech
Manufacturer and R&D of Corneal Contact Lens Care Technology and Products
Just Medical
Medical Device Research and Development, Production, and Sales
Lepu Medical
Interventional Pacemaker Manufacturers and Distributors
As of December 29, 2023,According to the requirements of the National Medical Products Administration's "Special Review Procedure for Innovative Medical Devices" (Announcement No. 83 of 2018 of the National Medical Products Administration), the Office for the Review of Innovative Medical Devices organized relevant experts to review the applications for special review of innovative medical devices and approved 67 application projects to enter the special review procedure.
A total of 9 official notifications were issued, organized by Siyu for readers' reference and review.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 9, 2023)
Publication Date: 2023-12-22
1. Product Name: Prostate Surgery Positioning Resection Hydroblade System and Disposable Prostatic Surgery Hydrodynamic Blade
Applicant: Beijing Zhiyu Medical Technology Co., Ltd.
2. Product Name: Disposable Ultrasound Thrombolysis Catheter
Applicant: Beijing Heqing Hechuang Medical Technology Co., Ltd.
3. Product Name: TIPS Covered Stent System
Applicant: Intervastec
4. Product Name: Interventional Ventricular Assist Device
Applicant: HearHill
5. Product Name: Interventional Ventricular Assist Device
Applicant: Shanghai Huanqing Medical Technology Co., Ltd.
6. Product Name: Tumor Electric Field Therapy Device
Applicant: Hebei Puni Medical Technology Co., Ltd.
7. Product Name: MRI-guided Laser Therapy Device
Applicant: Hangzhou Genlight Neurotech Co., Ltd.
8. Product Name: Rigid Contact Lens Cleaning and Disinfection Equipment
Applicant: Suzhou 3n Biological Technology Co., Ltd.
9. Product Name: Cardiac Pulsed Field Ablation Device
Applicant: Shanghai Shangyang Medical Technology Co., Ltd.
10. Product Name: Pulsed Electric Field Ablation System
Applicant: Hangzhou Ruidi Biotechnology Co., Ltd.
11. Product Name: Intracardiac Ultrasound Diagnostic System
Applicant: Xi'an Huafeng Medical Technology Co., Ltd.
12. Product Name: Biologic Knee Joint Prosthesis System
Applicant: Just Medical
13. Product Name: Intracranial Aneurysm Embolization System
Applicant: Beijing Taijie Weiye Technology Co., Ltd.
Public Notice of the Review Results for Special Review Applications of Innovative Medical Devices (No. 8, 2023)
Publication Date: 2023-11-09
1. Product Name: Digestive Endoscopy Surgical Assistance Operating System and配套用一次性使用Digestive Endoscopy Surgical Flexible Arm
Applicant: Shenzhen Rob Medical Technology Co., Ltd.
2. Product Name: Cardiac Pulsed Field Ablation System
Applicant: Shanghai Hongtong Industrial Co., Ltd.
3. Product Name: Implantable Cardiac Contractility Modulator
Applicant: Lepu Medical Electronic Instrument Co., Ltd.
4. Product Name: Disposable Peripheral Vascular Intravascular Ultrasound Catheter and Intravascular Ultrasound Therapy Device
Applicant: Beijing Huatong Jizhi Medical Device Co., Ltd.
5. Product Name: Transcatheter Aortic Valve System
Applicant: Suzhou Jiecheng Medical Technology Co., Ltd.
6. Product Name: Transapical Mitral Valve Chordae Repair System
Applicant: Hanxin Medical Technology (Shenzhen) Co., Ltd.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 7, 2023)
Publication Date: 2023-09-22
1. Product Name: Prostate Cancer MRI Image-Assisted Diagnosis Software
Applicant: Siemens Shanghai Medical Equipment Co., Ltd.
2. Product Name: Plasma Skin Therapy Device
Applicant: Hefei Zhongke Ion Medical Technology Equipment Co., Ltd.
3. Product Name: Auxiliary Detection Software for CT Angiography Images of Head and Neck Aneurysms
Applicant: Shanghai United Imaging Intelligence Healthcare Technology Co., Ltd.
4. Product Name: Disposable Coronary Rotablator Device
Applicant: Jiaxing Jiangxin Medical Technology Co., Ltd.
5. Product Name: Interventional Left Ventricular Assist System
Applicant: Anhui Tongling Biomimetic Technology Co., Ltd.
6. Product Name: Minimally Invasive Myocardial Rotary Cutting System
Applicant: Wuhan Microxin Tan Medical Technology Co., Ltd.
7. Product Name: Disposable Silicone Catheter
Applicant: Taizhou Dubomai Medical Device Co., Ltd.
8. Product Name: Abdominal Aortic Stent Graft System
Applicant: Hangzhou Weiqiang Medical Technology Co., Ltd.
9. Product Name: Multifocal Intraocular Lens
Applicant: Wuxi Leiming Vision Care Technology Co., Ltd.
10. Product Name: Multifocal Intraocular Lens
Applicant: Tianjin Century Kaitai Biomedical Engineering Co., Ltd.
11. Product Name: Human DNA Methylation Detection Kit (Reversible Terminator Sequencing Method)
Applicant: Guangzhou Burning Rock Medical Inspection Co., Ltd.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 6, 2023)
Publication Date: 2023-08-23
1. Product Name: Cardiac Cryoablation System
Applicant: Shanghai Antech Medical Technology Co., Ltd.
2. Product Name: Implantable Cardioverter Defibrillator
Applicant: Suzhou Wushuang Medical Equipment Co., Ltd.
3. Product Name: Single-Use Pressure Monitoring Pulsed Electric Field Ablation Catheter
Applicant: Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd.
4. Product Name: Single-Use Magnetic and Electric Positioning Pressure Monitoring Pulsed Electric Field Ablation Catheter
Applicant: Hunan Aipute Medical Device Co., Ltd.
5. Product Name: Pulsed Electric Field Ablation Device
Applicant: Shenzhen Maiwei Medical Technology Co., Ltd.
6. Product Name: Near-Infrared Light Brain Function Therapeutic Device
Applicant: Danyang Huichuang Medical Equipment Co., Ltd.
7. Product Name: Intracranial Aneurysm Interventional Surgery Simulation Software
Applicant: Sim Medical Company
8. Product Name: Human CDO1/AJAP1/GALR1 Gene Methylation Detection Kit (Fluorescence PCR Method)
Applicant: Wuhan Kaidewei Biotechnology Co., Ltd.
9. Product Name: Light-Curing Wound Sealing Adhesive
Applicant: Zhongshan Gohigh Medical Technology Co., Ltd.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 5, 2023)
Publication Date: 2023-07-11
1. Product Name: Glaucoma-like Fundus Changes Fundus Image Auxiliary Judgment Software
Applicant: Beijing Zhiyuan Huitu Technology Co., Ltd.
2. Product Name: Peripheral Thrombectomy Stent System
Applicant: Innary Medical Co., Ltd.
3. Product Name: Gastric Tumor Electronic Endoscopy Image-Assisted Detection Software
Applicant: Wuhan Chujingling Medical Technology Co., Ltd.
4. Product Name: Extracorporeal Ventricular Assist Device
Applicant: Suzhou Heart Power Medical Technology Co., Ltd.
5. Product Name: Peripheral Venous Thrombectomy Stent System
Applicant: Innary Medical Co., Ltd.
6. Product Name: Interventional Ventricular Assist Device
Applicant: Shenzhen Core Medical Technology Co., Ltd.
7. Product Name: Transcatheter Valve System
Applicant: Beijing Bioheart Medical Technology Co., Ltd.
8. Product Name: Boron Neutron Capture Therapy System
Applicant: Neuboron (Xiamen) Medical Device Co., Ltd.
9. Product Name: Phakic Intraocular Lens
Applicant: Aiborn Medical Technology Co., Ltd. (Beijing)
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 4, 2023)
Publication Date: 2023-05-26
1. Product Name: Knee Joint Prosthesis System
Applicant: Yabone Medical Technology (Suzhou) Co., Ltd.
2. Product Name: Intracardiac Ultrasound Imaging System
Applicant: Shenzhen Saihe Medical Technology Co., Ltd.
3. Product Name: Hybrid Closed-Loop Insulin Delivery System
Applicant: Microtech Medical (Hangzhou) Co., Ltd.
4. Product Name: Transcatheter Aortic Valve System
Applicant: Peijia Medical Technology (Suzhou) Co., Ltd.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 3, 2023)
Publication Date: 2023-04-24
1. Product Name: Fractional Flow Reserve Measurement System
Applicant: Chongqing Xinderite Medical Technology Co., Ltd.
2. Product Name: Navigation and Positioning Microwave Ablation System
Applicant: Zhen Health (Zhuhai) Medical Technology Co., Ltd.
3. Product Name: Intracranial Aneurysm Auxiliary Assessment Software
Applicant: Qianglian Zhichuang (Beijing) Technology Co., Ltd.
Public Notice of the Review Results for Special Review Applications of Innovative Medical Devices (No. 2, 2023)
Publication Date: 2023-03-17
1. Product Name: Extravascular Implantable Cardioverter Defibrillator System
Applicant: Medtronic
2. Product Name: Atrial Septal Puncture Kit
Applicant: Hangzhou Nuosheng Medical Technology Co., Ltd.
3. Product Name: Cardiac Electrophysiology Interventional Device Control System
Applicant: Shaoxing Mayo Heart Magnetic Medical Technology Co., Ltd.
4. Product Name: Multi-channel Cardiac Pulsed Field Ablation System
Applicant: Shanghai Xuan Yu Medical Device Co., Ltd.
5. Product Name: Pulmonary Artery Thrombectomy System
Applicant: Morningstar (Nantong) Medical Device Co., Ltd.
6. Product Name: Transcatheter Mitral Valve Clip System
Applicant: Yingmai Medical Technology (Shanghai) Co., Ltd.
7. Product Name: Transcatheter Mitral Valve Clip System
Applicant: Shanghai Handuyu Medical Technology Co., Ltd.
8. Product Name: Transcatheter Mitral Valve Clip System
Applicant: Shanghai Intervastec Medical Technology Co., Ltd.
9. Product Name: Transcatheter Tricuspid Valve Clip System
Applicant: Hangzhou Duanyou Medical Technology Co., Ltd.
Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 1, 2023)
Publication Date: 2023-02-20
1. Product Name: Carbon Fiber Artificial Ribs
Applicant: Hunan Tancong Biotechnology Co., Ltd.
2. Product Name: Transurethral Prostatic Urethral Lift System
Applicant: Younuowei (Wuhan) Medical Technology Co., Ltd.
3. Product Name: Flow Diverter Device
Applicant: Jiangsu Nuanyang Medical Device Co., Ltd.
