Medical device industry striding forward to high quality development
March 20, 2024
On December 18, the State Drug Administration announced that the innovative medical device "vertebral artery rapamycin targeted eluting stent system" produced by minimally invasive Shentong medical technology (Shanghai) Co., Ltd. was approved for listing. This is the 26th innovative medical device approved to be listed in China this year, and the 99th innovative product approved to be listed since the special approval procedure for innovative medical devices (Trial Implementation) laid the rapid approval channel for innovative medical devices in February 2014.
In recent years, with the deepening reform of China's medical device review and approval system, the medical device industry has maintained a good momentum of healthy and rapid development. With the burst of innovation and R & D vitality, the interconnection of knowledge and information, and the cross integration of new technology and new materials, more innovative medical devices have been accelerated to meet the needs of the public Speed up progress on the road of high-quality development.
"Intelligent manufacturing" products accelerate the emergence
In recent years, under the circumstances of more fierce market competition and complex and changeable international market, China's medical device industry has achieved reasonable growth in quantity and steady improvement in quality with the support of innovative medical device special review procedures, priority approval procedures and other policies. Moreover, China's medical device industry has achieved a breakthrough in some areas.
The reporter counted the innovative medical devices approved for listing since 2014. This year, the products approved are the most, and some of them are "eye-catching". Now in January, the innovative product "coronary blood flow reserve score calculation software" of Beijing Kunlun medical cloud Technology Co., Ltd., the first domestic artificial intelligence medical device in China, was approved for listing. It is understood that the product adopts the self-developed deep learning technology, and is the world's first three kinds of medical devices completely based on artificial intelligence deep neural network.
In fact, this year, the development of the artificial intelligence medical device industry ushered in major breakthroughs, the pace of technological breakthroughs and product landing in the industry has been accelerating, and the success stories of the artificial intelligence medical products have been spread frequently. In addition to the above products, the artificial intelligence "ECG analysis software" of Lepu medical, the MRI aided diagnosis software of intracranial tumor of ander medical, and the products of Shenzhen silicon based Intelligent Technology Co., Ltd "Diabetic retinopathy fundus image aided diagnosis software" and "diabetic retinopathy fundus image aided diagnosis software" of Shanghai Yingtong Medical Technology Co., Ltd. have been approved for listing. According to statistics, as of December 16, this year, 10 AI medical devices have been approved for marketing, and the transformation of domestic AI medical devices and other "intelligent manufacturing" achievements has been fast and steady.
In recent years, China's import substitution of high-end medical devices has accelerated, and the international market recognition has gradually improved. Wang Baoting, Deputy Secretary General of China pharmaceutical regulatory Research Association and chairman of medical device regulatory research professional committee, believes that China's foreign trade structure of medical devices continues to optimize, the proportion of high-end medical devices products has increased, and the quality and efficiency continue to improve.
According to the statistics of China Medical Insurance chamber of Commerce, China's medical device import and export trade has also maintained a sustained growth momentum for 11 years. In 2019, the export volume of medical devices will reach US $28.702 billion, with a year-on-year growth of 21.46%. Local high-end medical device enterprises such as Mindray medical, Neusoft medical, Wandong Medical and Lianying medical constantly promote high-quality development by introducing talents, technological innovation and other ways, and gradually emerge in the international market.
