Recently, the National Medical Products Administration (NMPA) of China approved the product registration application for "MoyoAssist® Extracorporeal Ventricular Assist System" developed and produced by magAssist., with the registration certificate numbers for the extracorporeal ventricular assist device "China Medical Device Registration Approval 20243100773", and the extracorporeal ventricular assist pump head and tubing "China Medical Device Registration Approval 20243100774".
It is worth mentioning that,MoyoAssist® is the first domestically produced extracorporeal ventricular assist device in China to feature full magnetic levitation technology and specialized consumables.This approval for marketing represents another new breakthrough in domestically produced high-end medical devices.
The innovation of China's medical devices is in a stage of rapid development. Support from the government, growth in market demand, advancements in technology, and participation from the capital markets have all provided favorable conditions for innovation and development within the industry. Against this backdrop, we have compiled the following summary of innovative medical devices that have been approved and launched in the market so far this year:
According to the official name currently disclosedAccording to the analysis, as of now in 2024, the official sources have announced a total of 25 Class III medical devices that have passed through the special review process for innovative medical devices (i.e.,Entering the Innovation ReviewBatchGreenChannel) Compared with 30 products in the same period of 2023, it decreased by 5. Among the products approved this year,Implantable devices account for a larger proportion, totaling 11, including 3 active implantable devices and 8 passive implantable devices.Medical Devices Approved through the Innovative Medical Device Special Review Process from January to April 2024In contrast, the review process for innovative product registration applications is more stringent. As of now, the National Medical Products Administration (NMPA) has announced that 15 medical devices have been approved for marketing.Same as 2023Phase 10An increase of 3 compared to before. Among the products approved for marketing in China this year, 8 areMade in China, 7 ofImported from the USA。
Innovative Devices Approved for Marketing in China from January to April 2024According to statistical data, in this yearApprovedAmong the innovative devices on the market, 46% are imported from the United States. As the largest medical device market globally, the FDA's approval status in the U.S. also receives significant attention.In the first quarter of 2024, the FDA approved a total of 691 products through the 510(k) pathway,Including 22 Class I devices and 646 Class II devices,One Class III medical device,Unclassified 22.The classification of devices based on the U.S. medical professional uses through the 510(k) premarket notification revealed that the largest number of approved types were orthopedic devices, general and plastic surgery devices, and radiology devices.Products that received pre-market approval (PMA) and were launched for the first time in Q1 2024:At present, globallyThe medical device industry is in a period of rapid technological development,According to multiple market research reports, stable growth is expected to continue in the coming years.The innovative medical device market is the most dynamic and growth-potential part of the medical device industry.In order to adapt to the rapid development of the innovative medical device industry, regulatory agencies are taking active measures., to ensure the safety and efficacy of the new product。▲ Source: Medical Device Innovation Network▲Please indicate the source above when reprinting.Disclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment; please evaluate carefully. If it involves the content, copyright, or other issues of the work, to protect the rights and interests of both parties, please contact us and we will handle it immediately. If any platform reprints this article, it must take responsibility for the content of the article itself; the Medical Device Innovation Network is not responsible for any secondary dissemination caused by the reprint.
