Innovative Medical Devices Special Review Application Examination Results Public Notice (No. 6 of 2026)
Zylox-Tonbridge
Innovative R&D, Production, and Sales of Medical Devices in the Vascular Intervention Field
WYTD
Developer of Cardiac Disease Diagnosis and Treatment Equipment
V-Onco
Irreversible Electroporation Technology Developer
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 be approved to enter the special review procedure and are now being publicly announced. The announcement period is from April 1, 2026, to April 16, 2026.
1. Product Name: Peripheral Dot Stent System
Applicant: Zylox-Tonbridge Medical Technology Co., Ltd.
2. Product Name: Ceramic Dental Implant System
Applicant: Beijing Ruici Medical Technology Co., Ltd.
3. Product Name: Patent Foramen Ovale (PFO) Closure Device
APPLICANT: WYTD MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
4. Product Name: Steep Pulse Treatment Device
Applicant: Hangzhou V-Onco Medical Technology Co., Ltd.
5. Product Name: Toric Posterior Chamber Phakic Intraocular Lens
Applicant: Wuxi Carl Zeiss Reming Eye Care Medical Technology Co., Ltd.
During the public announcement period, if any organization or individual has any objections, they may submit their objections in writing and send them to our center's email address: gcdivision@cmde.org.cn.
Special Note:
1. This public notice shall not serve as the basis for the aforementioned medical device to enter the innovative review process; whether it enters shall be subject to the final review conclusion.
2. 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 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, dedicated personnel responsibility, and scientific review, while ensuring that standards are not lowered and procedures are not reduced.
ComeSource: Center for Medical Device Evaluation, National Medical Products Administration
