China AI medical device market is still in its early stages. Only 47 AI medical devices have been approved for listing in China so far, but this is set to grow. The intersection of artificial intelligence (AI) and the medical device industry is becoming a new growth driver for the sector, according to a whitepaper released by the Intelligent Medical Device Industry Development Research Working Group.
On April 7, 2023, the Center for Medical Device Evaluation (CMDE) released an article to share an overview of the latest developments of the AI medical device industry in China, and also referred to the whitepaper issued by the Intelligent Medical Device Industry Development Research Working Group. According to the article, the medical device industry is a crucial area for building strong manufacturing capabilities and China’s medical device sector has grown rapidly in recent years. By the end of 2020, China’s medical device industry had generated over CNY 103.92bn in revenue, with a five-year compound annual growth rate of 10.5%. However, to continue this growth, high-end medical devices require the integration of AI, big data, and cloud computing to enable intelligent digital transformation, upgrade product performance and create leapfrog development opportunities.
AI medical devices are empowering the medical industry by improving the supply capacity of medical equipment, optimising treatment processes, and innovating medical methods. The use of AI technology is transforming diagnostic imaging equipment by enabling scanning and image reconstruction, which is essential for assisting doctors in accurate diagnoses. AI medical devices are also standardising clinical treatment practices and reducing medical errors, resulting in improved medical quality. The combination of AI medical devices and wireless communication technologies such as 5G is enabling remote collaboration between doctors, medical devices and patients, and advancing the detection time of some diseases.
The artificial intelligence medical device industry has high application value and wide coverage, attracting participation from enterprises and units across multiple fields. The industry ecosystem includes partners in areas such as standard specification, support environment, infrastructure, intelligent hub and intelligent application. To date, 47 AI medical devices have been approved for listing in China, covering cardiovascular, brain, eye, lung, orthopaedic, oncology and other disease areas, with expected uses including assisted triage and assessment, quantitative calculation, lesion detection, and target area outlining.
However, the development of the AI medical device industry is still in the early stages and a commercial closed loop has yet to be formed, with large-scale procurement based on clinical value yet to begin. While there have been breakthroughs at the registration access level, price access and health insurance access are still at an early stage. At the price access level, AI medical devices have not yet been included in the National Medical Service Price Item Specification, and only Shanghai, Guangdong and Shandong provinces and cities have included AI technology descriptions in their provincial medical service item filing lists.
Read the full CMDE article on AI medical devices industry development in China.
Discover our services for medical device registration, renewals and NMPA Legal Agent.