Approval of the "Green Channel" to Assist the Medical Device Industry in Innovative Breakthroughs

Staff Reporter Zhang Xiaoyu

The National Medical Products Administration (hereinafter referred to as “NMPA”) recently released the “2025 Medical Device Registration Work Report” (hereinafter referred to as “the Report”). The report shows that in 2025, the NMPA received a total of 457 applications for special approval of innovative medical devices, of which 104 were approved to enter the special review process for innovative medical devices; 38 priority applications were received, with 26 approved for expedited review.

The special review and priority approval processes for innovative medical devices are core policies that encourage medical device innovation and accelerate the market entry of urgently needed clinical products in China. Industry calls them the “green channel” for innovative product approval.

Under coordinated efforts of national and local policies, listed companies such as Shanghai United Imaging Healthcare Co., Ltd. (hereinafter “United Imaging”) and Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (hereinafter “Mindray”) rely on breakthroughs in core technology to accelerate product launches, steadily grow performance, and promote industry transformation from “scale expansion” to “innovation-driven.”

Hu Qimu, a specially appointed researcher of the China Enterprise Confederation, stated that the 2025 review and approval data reflect profound changes in the medical device industry ecosystem: on one hand, companies’ enthusiasm for innovation remains high, with application volumes staying at a high level, indicating that the industry has officially entered the innovation-driven stage; on the other hand, regulators are reasonably controlling approval rates, resolutely curbing “pseudo-innovation,” and creating space for high-quality enterprises with core technologies and clinical value to develop, thereby channeling innovation resources toward leading companies.

Continuous Improvement of the Innovation Ecosystem

The Report shows that in 2025, the NMPA approved 76 innovative medical devices, a 17% increase year-on-year; 25 medical devices received priority approval, a 212.5% increase. Approved products cover cutting-edge fields such as artificial intelligence, tumor radiotherapy, and biomedical materials.

Xu Jiarui, director of the Data Center at Guangdong Research Institute of New Biological Materials and High-End Medical Devices, told Securities Daily that the innovation and priority approval data released by the NMPA in 2025 clearly outline the key features of China’s medical device innovation shifting from quantity explosion to qualitative leap, also reflecting a more mature, precise, and efficient review system.

“Compared to previous years, the continuous expansion of innovation channel applications and the significant increase in approved applications for priority channels are not due to relaxed review standards but are supported by more focused directions and optimized service mechanisms,” Xu further explained. The NMPA maintains the core threshold for innovation channels—“domestically first, internationally leading, with significant clinical value”—and has established multiple joint innovation cooperation platforms involving multiple ministries, strengthening early intervention and full-process guidance to facilitate the transformation of innovative achievements. The substantial increase in approved applications through the priority channel is a targeted acceleration by regulators for products urgently needed in clinical settings, with supply shortages or major national science and technology projects, featuring clearer standards and smoother processes.

If the approval data from the NMPA is the “fruit,” then the recent intensive policies introduced across various regions to support industry are the “soil” for cultivating innovation. Since the second half of 2025, Beijing, Shanghai, Guangdong, Anhui, Hubei, Shandong, Guangxi, and other regions have successively launched major policies to support the entire chain of medical device development.

For example, the Beijing Municipal Bureau of Economy and Information Technology and five other departments jointly issued the “Measures for Promoting High-Quality Development of the Medical Device Industry in Beijing,” proposing 15 specific measures across five dimensions: clinical R&D, achievement implementation, ecological clustering, digital empowerment, and open cooperation.

The Shanghai Municipal People’s Government Office issued the “Several Measures to Deepen the Reform of Drug and Medical Device Regulation and Promote High-Quality Development of the Pharmaceutical Industry,” introducing 22 measures across six dimensions. Shanghai emphasizes strengthening full lifecycle digital regulation, building a digital regulatory platform, and applying technologies such as “AI + intelligent review and approval” and “AI + on-site supervision” to improve regulatory efficiency.

Leading Companies Seize the Opportunity

Under the policy tailwinds, listed medical device companies leveraging R&D investment, industrialization capacity, and compliance advantages have become the biggest beneficiaries of the innovation approval channels. Many high-end products have been rapidly approved and launched, with technological breakthroughs directly translating into performance growth.

OPKO Health Technology Co., Ltd. is a typical example. As a leader in the domestic corneal reshaping lens field, its subsidiary Jiangsu Duozhi Medical Technology Co., Ltd. has had its application for the medical device “Flexible Hydrophilic Contact Lens” accepted by the NMPA. This product is a Class III medical device used for daily correction of refractive errors.

Beyond ophthalmic devices, companies in high-end medical imaging, AI medical care, and vascular intervention sectors also reaped significant benefits from the 2025 innovation approval process.

United Imaging, a leader in high-end medical imaging equipment in China, delivered a highly representative result in 2025. The company’s self-developed China’s first photon-counting spectral CT—uCT Ultima—was officially approved for market launch in 2025. This product not only passed the special review process for innovative medical devices but also marked China’s break in the long-standing monopoly of GE, Philips, and Siemens in this field, becoming the first Chinese company to commercialize this technology globally. Additionally, the world’s first “imaging” MRI, uMR Ultra, was also approved in the same year.

Technological breakthroughs directly translated into performance growth. According to United Imaging’s 2025 annual performance report released on February 26, the company achieved a total revenue of 13.821 billion yuan, a 34.18% increase year-on-year; net profit attributable to shareholders was 1.888 billion yuan, up 49.60%, with net profit after non-recurring gains and losses increasing by 77.01%.

Besides United Imaging, Mindray benefited from the priority approval process in AI-enabled ultrasound imaging, and Shenzhen Huitai Medical Devices Co., Ltd. in electrophysiological intervention innovation products, further consolidating their leading positions in their respective segments.

Hu Qimu stated that in the future, listed companies with core technologies, clear clinical value, and well-established intellectual property rights will continue to benefit from the “green channel” approval process.