76 Innovative Medical Devices Approved for Launch in 2025!

Recently, the National Medical Products Administration (NMPA) released the 2025 Annual Report on Medical Device Registration Administration (hereinafter referred to as the "Report"). According to the Report, both the number of medical device applications accepted and registrations approved by the NMPA in 2025 were higher than the previous year. A total of 76 innovative medical devices were approved for launch throughout the year, representing a year-on-year increase of 17%. Meanwhile, 25 medical devices were granted priority review and approval, up 212.5% year-on-year. The approved products cover multiple cutting-edge fields including artificial intelligence, tumor radiotherapy, and biomedical materials.

Approval of New Medical Devices

In 2025, the NMPA received 457 applications for the special approval pathway for innovative medical devices, of which 104 were approved to enter the special review procedure for innovative medical devices. It received 38 applications for priority review, of which 26 were granted priority review.A total of 76 innovative medical device products were approved for launch in 2025, an increase of 17% compared with 2024.

The top five categories of innovative medical devices approved in 2025 were:active surgical instruments, passive implantable devices, active implantable devices, ophthalmic devices, and neurological & cardiovascular surgical instruments.Compared with 2024, passive implantable devices and ophthalmic devices achieved rapid growth in innovative products.Ophthalmic devices stood out prominently: 6 products were approved, including phakic intraocular lenses and extended depth-of-focus intraocular lenses, whereas no innovative ophthalmic medical devices were approved in this category in 2024.

The Report shows that from 2014 to 2025, a total of 391 innovative medical devices were approved, including:

• 336 domestic innovative medical devices from 223 enterprises across 17 provinces;

• 55 imported innovative medical devices from 30 enterprises in 6 countries.

Beijing, Shanghai, Jiangsu, Guangdong and Zhejiang ranked highest in the number of approved innovative medical devices and corresponding enterprises, accounting for approximately 73.9% of the 391 total approved innovative medical devices.

Policy Highlights

The Report points out that in 2025, the NMPA continued to improve the mechanism supporting the development of innovative medical devices, advanced the reform of the medical device review and approval system in depth, strengthened medical device registration administration and review capacity, enhanced the safety of medical devices for the public through improved regulatory efficiency, and empowered high-quality industrial innovation.

The NMPA focused on supporting breakthrough innovations in key medical device fields:

• Issued the Announcement on Optimizing Full-Life Cycle Regulation to Support the Innovation and Development of High-End Medical Devices to support the high-end medical device industry through integrated policy innovation.

• Developed a working mechanism for the first launch of "globally innovative" medical devices in China to proactively foster domestically developed "global first-in-class" products.

• Focused on core fields such as brain–computer interfaces and high-end imaging equipment, and released the Priority Review Catalog for High-End Medical Devices (2025 Edition).

The NMPA implemented targeted measures to meet clinical needs:

• Launched the pilot "Spring Rain Action" in 11 provinces with strong medical device innovation R&D capabilities to promote clinical value-oriented original innovation and achievement transformation of medical devices.

• Approved 7 antigen detection kits for influenza A/B for home self-testing, expanding respiratory disease testing to household scenarios.

• Approved 8 rare disease diagnostic reagents, enabling effective treatment through accurate identification.

The NMPA continuously improved the scientific and smart regulation level:

• Conducted 10 forward-looking regulatory science projects in key medical device fields such as brain–computer interfaces, artificial intelligence, and new biomedical materials.

• Accelerated the improvement of medical device review and approval capacity, issuing guidance on provincial-level medical device review quality management systems to promote consistent and effective review across the system.

Source: National Medical Products AdministrationReposted from: Guangdong Medical Products Administration