Five Innovative Medical Devices Enter China's Fast-Track Review Program, Companies File IPO Prospectuses

Jul 01, 2026 19:30 CST Updated 19:30

Oculotronics

Ophthalmic Microsurgery Robot Developer

ZhiZhongPossesses extensive expertise in innovative regulatory submissions for high-end implantable and interventional devices and medical imaging equipment/software—such as transcatheter aortic valve systems, neurosurgical robotic systems, ventricular assist devices, endoscopic ultrasound systems, all-digital PET/CT scanners, and AI-assisted diagnostic software—as well as for in vitro diagnostic reagents, including digital PCR analyzers, high-throughput gene sequencing reagents (for HPV, chromosomal abnormalities, and monogenic disorders), flow cytometry/fluorescence cell detection reagents, and soluble protein detection reagents. Provides comprehensive end-to-end market launch services for various medical devices, covering innovative product registration, regulatory compliance, and clinical trials.

Public Notice of Review Results for Special Examination Applications for Innovative Medical Devices (No. 11, 2026)

Pursuant to the “Special Review Procedures for Innovative Medical Devices” (Announcement No. 83 of 2018 issued 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 of innovative medical devices. It is proposed that the following applications be accepted into the special review procedure, and this is hereby announced for public notice. The public notice period is from June 30, 2026, to July 14, 2026.

1. Product Name: Vascular Graft

Applicant: CAREVITA

2. Product Name: Ophthalmic Surgical Assistance System

Applicant: Guangzhou Oculotronics Medical Instrument Co., Ltd.

3. Product Name: Digestive System DNA Fragment Characteristic Detection Kit (Combined Probe Anchored Polymerase Sequencing Method)

Applicant: Geneseeq Medical Device and Diagnostic Inc.

4. Product Name: Puncture Surgery Navigation and Positioning System

Applicant: Beijing Yiru Jingzhi Medical Technology Co., Ltd.

5. Product Name: Abdominal Aortic Stent Graft System

Applicant: Lombard Medical Co., Ltd.

During the public notice period, any entity or individual with objections may submit written comments 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 devices to enter the innovative review procedure; whether they enter such procedure shall be subject to the final review conclusion.

2. Entry into the innovative review process does not constitute a determination that the product has been found safe and effective for registration approval. Applicants are still required to conduct research and development and submit registration applications in accordance with relevant requirements. The 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, under the premise that standards are not lowered and procedures are not reduced.

National Medical Products Administration

Center for Medical Device Technical Evaluation

June 30, 2026

The following is a summary by Zhizhong of all products approved through the innovative approval pathway in 2026:

Source:CMDE

Compiled by: ZhiZhong TACRO
[Disclaimer] Some articles and information are sourced from the internet and do not represent the views or positions of this subscription account. If there are any issues such as copyright disputes regarding the reproduced content, please contact us immediately (Lin 18571579167), and we will promptly take appropriate measures.
Recent Activities


[Online Course Preview] Tools for Evaluating Clinical Evidence of Medical Devices—How to Conduct Effective Meta-Analysis
[Suzhou] July 7! AI Medical Devices × BCI Brain-Computer Interface Exchange Meeting