Eight Innovative Medical Devices Enter China's Priority Review Pathway

(Source: Medical Device Innovation Network)

Innovative MedicalPublic Notice of the Review Results for the Special Review Application of Medical Devices (No. 5, 2026)

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 March 26, 2026, to April 10, 2026.

1. Product Name: Self-expanding Intracranial Aneurysm Occluder

Applicant: Deepintec Scientific Co., Ltd.

2. Product Name: Dura Mater Medical Adhesive

Applicant: Medprin

3. Product Name: Transcatheter Mitral Valve Replacement System

Applicant: Shanghai NewMed Medical Co., Ltd.

4. Product Name: Interventional Right Ventricular Assist Device

Applicant: Shenzhen Core Medical Technology Co., Ltd.

5. Product Name: Implantable Spinal Cord Stimulation System

Applicant: Leadinno Medical Valley

6. Product Name: Mycobacterium Nucleic Acid Detection and Mycobacterium Tuberculosis Drug Resistance Gene Detection Kit (Nanopore Sequencing Method)

Applicant: Hangzhou Shengting Medical Technology Co., Ltd.

7. Product Name: Gene Sequencer

Applicant: Chengdu Jinshi Technology Co., Ltd.

8. Product Name: Steep Pulse Ablation Instrument

Applicant: Hangzhou Ruidi Biotechnology Co., Ltd.

During the public announcement period, any organization or individual with objections may submit their opinions in writing and send them 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 recognized as having the safety and effectiveness required for registration. The applicant still needs to carry out research and development and submit a registration application according to 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, without lowering standards or reducing procedures.

National Medical Products Administration

Center for Medical Device Evaluation

March 26, 2026

▲ Source of the article:Center for Medical Device Evaluation

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