CMDE Announces Results of Special Review for Innovative Medical Devices (No. 8, 2023)

Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 8, 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 proposed to approve the following application projects to enter the special review procedure, which are now announced for public disclosure.

1. Product Name: Flexible Arm for Digestive Endoscopy Surgical Assistance Operating System and Associated Single-Use Accessories

Applicant: ROBO Medical

2. Product Name: Cardiac Pulsed Field Ablation System

Applicant: Shanghai Hong Tong Industries Inc. Co., Ltd.

3. Product Name: Implantable Cardiac Contractility Modulator

Applicant: Lepu Medical Electronic Instrument Co., Ltd

4. Product Name: Single-use 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: CAUSPER MEDICAL INC.

6. Product Name: Transapical Mitral Valve Chordae Repair System

Applicant: Hanxin Medical Technology (Shenzhen) Co., Ltd.

　　Publicity Period: From November 9, 2023 to November 23, 2023

During the public announcement period, if any organization or individual has objections, they may submit their concerns in writing, by phone, or via email to the Comprehensive Business Department of our center.

　　Contact Person: Zhang Xin

　　Phone：010-86452928

　　Email：gcdivision@cmde.org.cn

　　Address: Building 1, Yard 50, Meteorology Road, Haidian District, Beijing

　　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. 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.