Eight Innovative Medical Devices Enter China's Fast-Track Review Program
ScieHome
Developer of Ultrasound Energy Technology and Pharmaceutical-Device Combination Technology
Balance Medical
Producer of Cardiovascular Disease Implant Devices and Surgical Soft Tissue Repair Materials
Mindray
Medical Device R&D Manufacturer
AK Medical
Medical Device R&D Manufacturer
SceneRay
Innovative High-Tech Medical Device R&D and Manufacturer
According to the "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 procedure and are now being publicly announced. The announcement period is from September 5, 2025, to September 19, 2025.
1. Product Name: Ultrasonic Thrombolysis Device and Single-Use Ultrasonic Thrombolysis Catheter
Applicant: ScieHome
2. Product Name: Radiofrequency Ablation System
Applicant: Beijing Balance Medical Technology Co., Ltd.
3. Product Name: Adjustable Diameter TIPS Covered Stent System
Applicant: MEImedical
4. Product Name: Magnesium Alloy Hollow Bone Screw
Applicant: Suzhou Innokon Medical Technology Co., Ltd.
5. Product Name: Anesthesia System
Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
6. Product Name: Hip Joint Prosthesis Components
Applicant: AK Medical Holdings Limited
7. Product Name: Spinal Surgery Navigation and Positioning System
Applicant: Spring Rain (Suzhou) Intelligent Medical Technology Co., Ltd.
8. Product Name: Implantable Deep Brain Neurostimulator
Applicant: SceneRay Co., Ltd.
During the public notice period, any organization or individual with objections may submit written opinions 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 effectiveness required for registration approval. The applicant must still 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, while ensuring that standards are not lowered and procedures are not reduced.
National Medical Products Administration
Center for Medical Device Evaluation
September 5, 2025
Compiled by: TACRO
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