The China MedTech Edge: October 2025 Intelligence Briefing

Regulation on Clinical Translation of Biomedical New Technologies
On October 10, the State Council announced the Regulation on the Administration of Clinical Research and Clinical Translation and Application of Biomedical New Technologies (State Council Order No. 818). The regulation will take effect on May 1, 2026. This regulation systematically standardizes the definition of biomedical new technologies, the record-filing procedures and implementation of clinical research, and the application for and use of subsequent clinical translation.

It provides a solid legal guarantee for the development of technological innovation and the prevention and control of safety risks.

15 Recommended Medical Device Industry Standards
On October 30, the National Medical Products Administration (NMPA) issued the Announcement on the Release of 15 Recommended Medical Device Industry Standards, including YY/T 0910.2—2025 Medical electrical equipment — Medical imaging display systems — Part 2: Acceptance and constancy tests for medical imaging display systems (Announcement No. 106 of 2025).

The 15 industry standards cover fields such as medical imaging display systems, dentistry, portable electric infusion pumps, medical clean workbenches, neurotoxicity evaluation, Artificial Intelligence (AI) medical devices, and robotic surgery assisted equipment.

Extended Depth of Focus Intraocular Lens (Century Healthcare)

This innovative product is a single-piece posterior chamber intraocular lens (IOL) constructed from a hydrophobic acrylic material. It is engineered with a complex optical design to address vision correction following cataract surgery in adults. The lens achieves its primary goal of extended depth of focus through a unique structure: the anterior optical zone features an aspheric lens surface combined with a diffractive ring design, while the posterior surface is spherical. By utilizing multiple diffraction orders, the IOL expands the range of focus, specifically improving intermediate vision and thereby reducing the patient’s reliance on spectacles for daily activities.

MR-Monitored Semiconductor Laser Therapy System, Single-Use Laser Fiber Kit, and Stereotactic Surgery Planning Software (Genlight)

This comprehensive system provides a minimally invasive solution for neurosurgical intervention. The core component, the MR-Monitored Semiconductor Laser Therapy System, is used in conjunction with a Single-Use Laser Fiber Kit to perform localized laser ablation of lesions. This treatment is specifically indicated for patients suffering from drug-refractory epilepsy, particularly those with a clearly defined epileptogenic zone or seizure propagation pathway. The system is further supported by the Stereotactic Surgery Planning Software, which integrates with the laser therapy device to accurately plan and guide the head stereotactic surgical procedure, ensuring precise targeting during the operation.

Cardiac Electrophysiology Interventional Surgery Control System (Meio Cardinav Medical)

The Cardiac Electrophysiology Interventional Surgery Control System is designed to significantly enhance safety and precision during complex catheter ablation procedures. It utilizes a remote control system to execute the necessary manipulations of electrophysiology catheters and sheaths, moving away from the traditional, manually operated method at the patient’s bedside. A key feature is the system’s ability to provide a real-time, graphical representation of the catheter-sheath relationship during the procedure. This advancement resolves a major limitation of conventional surgery, where the fixed-curve sheath often remains invisible within 3D mapping systems, ultimately leading to a higher level of surgical safety and control.

Novogene: On October 20, Novogene officially announced the grand opening and commencement of operations of its new laboratory in Beaverton, Oregon, USA. The launch of this lab is a key step for Novogene to continuously advance its “global localization” strategy, providing more efficient and high-quality genomic technology solutions for local research and industry clients.

Oriental Gene: On October 27, Oriental Gene announced that its Time-Resolved Fluorescence Immunoassay products recently obtained a total of 36 medical device registration certificates in countries including the European Union, Colombia, Indonesia, and Saudi Arabia.

Cygnus: In October, Cygnus, a domestic gene sequencing platform enterprise, announced the completion of a new round of financing exceeding 100 million RMB, with capital transfer finalized. The company stated that the funds will primarily be used for continued R&D, product iteration, and commercial network expansion.

Leadinno Medical Valley: Recently, Leadinno Medical Valley completed nearly 200 million RMB in Series B financing. The company focuses on wireless energy transfer and closed-loop neuromodulation systems. This round of financing will further accelerate its product development and commercialization layout in core neuromodulation sectors, including Spinal Cord Stimulation (SCS), Peripheral Nerve Stimulation (PNS), Sacral Nerve Stimulation (SNS), and Deep Brain Stimulation (DBS). It will also drive breakthroughs in capacity upgrading and talent development.

Medprin: On October 16, Medprin announced its plan to acquire 100% of the equity of Easycess Medical from 10 counterparties through a combination of share issuance and cash payment. Upon completion, the transaction is expected to further expand the company’s product categories, forming a diversified product matrix, thereby enhancing its market competitiveness in the fields of neurosurgery and neuro-intervention.

BrainAid: On October 22, BrainAid announced the completion of over 10 million RMB in financing. The company stated that the financing will mainly be used to continue advancing NSR technology R&D and clinical verification; accelerate product deployment in medical institutions, health check centers, schools, and community settings; promote medical insurance access and the construction of a testing standard system; and expand the downstream product lines for intervention and health management.