China's MedTech Industry Enters a New Phase of Innovation-Driven Quality Enhancement in 2026

　　【Pharmaceutical Network Industry DynamicsIn recent years, domestically produced medical devices have entered a high-quality development phase driven by policy incentives and technological breakthroughs, with innovation outcomes in the medical device industry accelerating.
 

According to statistics, in 2025, the National Medical Products Administration (NMPA) accepted a total of 14,647 medical device registration applications, representing a year-on-year increase of 5.9%; throughout the year, 14,187 registrations were approved, marking an 8% year-on-year increase. Among these, 76 innovative medical devices were approved for marketing, reflecting a 17% year-on-year increase, with a cumulative total of 391 approvals; 25 medical devices were granted expedited review and approval for marketing, showing a 212.5% year-on-year increase, with a cumulative total of 171 approvals.
 

It is worth mentioning that, under the drive of innovation, a large number of domestically produced innovative medical devices have been approved since 2026. For instance, on February 28, the National Medical Products Administration approved the registration application for the thermal vapor therapy device and the disposable prostate thermal vapor therapy instrument from MedTecX Co., Ltd. The thermal vapor therapy device is used in conjunction with the disposable prostate thermal vapor therapy instrument to alleviate symptoms and obstructions associated with benign prostatic hyperplasia, suitable for male patients aged 50 years or older with a prostate volume of 30-80 cm³ due to benign prostatic hyperplasia.
 

On February 27, the registration application for the intravascular ultrasound treatment device and the disposable coronary intravascular ultrasound guidewire of Shanghai MicroPort Melody Medical Technology Co., Ltd. was approved. The intravascular ultrasound treatment device consists of a main treatment unit, a treatment handle, and a power cord; the disposable coronary intravascular ultrasound guidewire is composed of a guidewire, a tightening handle, and a sterile sheath. These two devices are used together for percutaneous coronary intervention (PCI) in adult patients with chronic total occlusion (CTO) lesions in the coronary arteries. They utilize mechanical vibration to open up proximal lesion tissue, assisting either a guidewire or a balloon in passing through the lesion.
 

On February 9, Kokai (Nantong) Life Sciences Co., Ltd.'s innovative product registration application for the transcatheter aortic valve system was approved. This product is suitable for patients who, after assessment by a cardiac team in conjunction with a scoring system, are considered to have symptomatic, severe aortic valve insufficiency (severe aortic regurgitation) and are not suitable for conventional treatment.Surgical OperationPatients with valve replacement aged 70 years or older.
 

In February, the registration application for the Nd:YAG laser therapy machine from Jilin Province's Keying Medical Laser Co., Ltd. was approved. This product is used for stone fragmentation under endoscopy in the urinary and biliary systems, with the aim of improving treatment safety and reducing damage to the soft tissue walls of the biliary and urinary systems.
 

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From a holistic perspective, in the complex market environment, China's medical device industry has embarked on a steady development path driven by innovation. It exhibits distinct characteristics of "technological breakthroughs, market expansion, and accelerating globalization." Against this backdrop, industry experts predict that 2026 will be a year of accelerated growth for China’s medical device industry. In that year, "high-quality development" has been written into the government work report, listed alongside innovative pharmaceuticals, marking the industry's official transition from the "first half" of scale expansion to the "second half" focused on innovation and quality enhancement. Driven by both policy incentives and technological advancements, domestically produced medical devices are expected to achieve systematic breakthroughs in high-end fields, leading to profound transformations in the industry landscape.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.