The National Medical Products Administration (NMPA) released its 2025 Annual Medical Device Registration Report, highlighting accelerated innovation in China’s medical technology sector. The agency approved 76 innovative medical devices in 2025, representing a 17% year‑on‑year increase, with priority review approvals surging 212.5% to 25 devices. Approved products span artificial intelligence, radiation oncology, and biomedical materials, reflecting China’s advancing capabilities in cutting‑edge healthcare technology.
2025 Approval Statistics
Metric
2025
YoY Change
Total Innovative Device Approvals
76
+17%
— Active Medical Devices
45
—
— Passive Medical Devices
29
—
— IVD Reagents
2
—
Priority Review Approvals
25
+212.5%
Top Five Innovation Categories
Rank
Category
Growth Notes
1
Active Surgical Instruments
Leading category
2
Passive Implantable Devices
Rapid growth vs. 2024
3
Active Implantable Devices
Core cardiovascular/neuro technology
4
Ophthalmic Devices
Rapid growth vs. 2024
5
Neurological and Cardiovascular Surgical Instruments
High‑precision intervention tools
Innovation Requirements
Criterion
Standard
IP Protection
Chinese invention patents or state‑disclosed patent applications
Novelty
Domestic pioneer in primary working principles/mechanisms
Innovation Acceleration: The 17% approval growth and 212.5% priority review surge signal NMPA’s commitment to streamlined pathways for breakthrough devices, reducing time‑to‑market for domestic innovators.
AI and Digital Health: Inclusion of artificial intelligence among top fields validates China’s AI‑enabled medical device strategy, spanning imaging, diagnostics, and surgical planning.
Implantable Device Growth:Rapid growth in passive implantables and ophthalmics reflects maturing domestic capabilities in structural heart, orthopedic, and vision restoration technologies.
IP and Pioneer Status: The patent protection and domestic pioneer requirements incentivize original R&D while protecting against copycat products, fostering sustainable innovation ecosystems.
Increased competition from domestic innovators; partnership and localization opportunities
Healthcare Providers
Broader access to advanced AI‑enabled and robotic surgical technologies
Investors
212.5% priority review growth signals regulatory support for medtech venture capital
Forward‑Looking Statements This brief contains forward‑looking statements regarding 2026 approval trends, category growth projections, and market access expansion. Actual results may differ due to risks including regulatory policy shifts, competitive dynamics, and reimbursement negotiation challenges.-Fineline Info & Tech
By Fineline Cube