Domestic Medical Device Firms Spark R&D Surge with 28 Innovative Products Approved in H1

　　【Pharmaceutical Network Industry Dynamics】Medical devices are an important material foundation for healthcare and the health industry, and are crucial to the life safety and health of the people. China's medical device industry started relatively late but has developed rapidly. This year alone, China has seen a large number of domestically produced innovative medical devices registered and launched in the market.
 

Recently, after review, the National Medical Products Administration (NMPA) has approved the registration of the innovative product "ValveClamp® Mitral Valve Clip System" produced by Shanghai Hanyu Medical Technology Co., Ltd. The product consists of a mitral valve clip, a delivery system, and a transvalvular device, utilizing an apical approach for surgery. It is suitable for patients assessed by a specialized cardiology treatment team to have...Surgical OperationHigh-risk patients with degenerative mitral regurgitation (MR≥3+) and suitable mitral valve anatomy.
 

Public information first: Hanyu Medical is a medical technology company dedicated to the research and development and commercialization of innovative medical devices in the field of structural heart disease. Previously, the only mitral valve repair device approved for marketing in China was Abbott's Mitraclip product. The approval of the ValveClamp registration application this time has broken foreign monopolies, becoming the first domestically produced mitral regurgitation interventional device approved for marketing in China.
 

In April, Yuanhua Intelligent Technology (Shenzhen) Co., Ltd. independently developed China's first hip and knee integrated surgeryRobotThe system has officially entered the market. This robot, equipped with independently developed navigation solutions, software systems, and core components, can assist doctors in performing various orthopedic surgeries such as total knee replacement, total hip replacement, unicompartmental knee replacement, spinal and trauma procedures. It is the first integrated hip and knee joint system independently developed in China.
 

In January, the National Medical Products Administration (NMPA) granted emergency approval, after review, to Shanghai Hanyu Medical Technology Co., Ltd. for the registration of its extracorporeal cardiopulmonary support device and disposable membrane oxygenator kits. When used together, these devices are intended for adult patients with acute respiratory failure or acute cardiopulmonary failure whose conditions are difficult to control with other treatments and who face foreseeable risks of disease progression or death. As China’s first domestically produced ECMO device and consumables kit, these products have independent intellectual property rights, with performance indicators that generally meet international standards for similar products.
 

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It is reported that in recent years, with the National Medical Products Administration (NMPA) accelerating and strengthening the formulation and revision of supporting regulations such as drug and medical device registration management methods, continuously releasing policy benefits, and successively issuing the Special Review Procedure for Innovative Medical Devices and the Priority Approval Procedure for Medical Devices, which have enabled innovative products and clinically urgently needed products to be evaluated more quickly, an increasing number of medical companies have started to accelerate research and development and promote the implementation of innovative technologies.
 

According to data from the National Medical Products Administration, as of July this year, China has approved a total of 217 innovative medical devices. In just the first half of this year, 28 innovative medical devices were approved for marketing.
 

The industry believes that, with strong support policies in the future and the ever-expanding large market for medical equipment, relevant enterprises will closely follow policy guidance, continuously increase R&D investment, accelerate breakthroughs in technology, especially in key core technologies, and further promote the high-quality development of China's medical device industry.
 

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