The release date is August 17, 2006.
The rapid development of industrial regulations has not kept up with the expectations of medical software management. In recent years, as the medical device industry continues to grow and information technology becomes more widely applied, medical software products are emerging and gaining attention across various sectors. However, compared to traditional medical devices, the management of medical software in China still lags behind. This issue has started to draw the attention of relevant regulatory authorities at both the industry and national levels. This information was shared by a reporter at a seminar on medical software products organized by the China Medical Device Industry Association.
The medical software industry is booming. Li Yuexi, manager of the Strategic Development Department at Beijing Wandong Medical Equipment Co., Ltd., told reporters that with the rise of the IT era, the software industry has had a significant impact on the medical device sector. The development of systems like HIS (Hospital Information System), PACS (Picture Archiving and Communication System), and RIS (Radiology Information System) has changed the previous perception of the medical device industry, which was once seen only as mechanical equipment manufacturing. Today, as computers become more common and chips become cheaper, people increasingly view medical imaging equipment as an information terminal or node that integrates data collection, processing, and display, even as part of a larger network. As a core component of IT, software is influencing product forms, service methods, production processes, human resources, business models, and customer value in the medical device industry. In particular, various types of medical software, including embedded software, are expected to bring new opportunities for the future of the industry.
Take embedded software as an example. With the growth of the IT industry and the shift in economic development, embedded computing systems have been widely used in various devices in recent years. Scientists believe that embedded technology is one of the greatest inventions of humanity after the personal computer and the Internet. In 2004, the global output value of embedded system products reached $200 billion, while the output value of embedded software in China reached 66 billion yuan. As digitalization, intelligence, and networking continue to expand globally, the embedded system market is expected to maintain double-digit growth. Currently, the transformation and innovation of traditional industries provide space for the development of the embedded software industry. Embedded applications in medical devices are gradually being promoted, such as MRI machines and monitoring systems. Modern Medical Instruments and electromechanical products require dedicated embedded system software support. These demands have greatly driven the development and industrialization of embedded systems. For instance, the software content in products like Mindray’s monitors and ultrasound devices accounts for about 60% of their value, with embedded software contributing over 30% of the total equipment output.
Embedded software is just one part of the diagnostic and treatment process when combined with medical devices. There is also medical software that only handles data transmission or image processing without being directly tied to the medical device itself. With the continuous advancement of medical information technology and the emergence of telemedicine, these latter two types of software have appeared in recent years. Li Yuexi believes that in the information age, medical devices are becoming more and more like multiple information terminals or nodes, which will have a significant impact on the development of the medical device industry.
However, the management of medical software remains lagging. Undoubtedly, the huge market potential is driving the rapid growth of the medical software industry. Yet, for any emerging industry, during its early stages of development, it often faces challenges related to outdated regulatory frameworks and management models. When the industry reaches a certain stage, standardized management inevitably becomes a priority. This is an objective law of development. Today, the medical software industry is facing similar issues.
According to Tian Yanfang, director of the Quality Management Department at Neusoft Digital Medical Systems Co., Ltd., China’s existing "Administrative Measures for the Registration of Medical Devices" (Order No. 16) applies to all types of medical device registration. However, there are areas where it does not align with the specific conditions of software-based equipment. Most of the provisions under Order No. 16 were designed for hardware-based devices, making it difficult to fully guide the registration of emerging medical software. Therefore, there is an urgent need for additional regulations and guidance documents.
Tian Yanfang explained that China's current medical device classification method is based on the "Medical Device Classification Rules" and implemented through the "Medical Device Classification Catalogue." However, the contents of the catalogue do not always align with the rules, and the relevance of the classification judgment table is unclear, especially when it comes to software. According to the rules, only software that controls the function of medical devices is classified in the same category as the devices themselves. Other types of software, such as image post-processing software, are not clearly defined. As a result, companies not listed in the catalogue face difficulties in understanding how to register their products.
In addition, the existing software classification does not fully reflect the actual structure of medical software. In hospital settings, application modules and software components from different departments are becoming increasingly integrated. According to the current classification code 6870, some medical software may fall into multiple categories simultaneously. While the "Beijing High Medical Device Software Product Supervision and Management Regulations (Temporary)" attempts to categorize software into management and analysis software, the definitions remain vague. For example, image processing and embedded software are not clearly defined, and the regulation lacks detailed specifications for software product management.
Sun Li, a registered engineer at Shenzhen Mindray Biomedical Electronics Co., raised concerns about the registration process. She questioned whether all software needs to be registered or tested, and if software updates require re-registration. She noted that even minor version changes might not necessitate re-registration unless they involve changes to standards or application scope. However, enforcement agencies often penalize manufacturers for mismatched model numbers, even when valid documentation is provided.
Another challenge is type testing. Due to the differences between software and hardware, using hardware testing methods for software can lead to incomplete evaluations. Tian Yanfang pointed out that third-party testing according to registration standards is only a partial part of enterprise verification and has limited significance. Some experts highlighted that certain medical device testing centers lack the necessary software testing capabilities, making it difficult to fully utilize test reports.
Shen Ran, a registered director at Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., emphasized the importance of tracing the entire product development process during final product inspection. He suggested that if enterprises implement proper system management, product quality can be ensured, and testing would be easier to conduct.
In the Beijing Municipal Drug Administration’s regulations, both management and analysis software must submit clinical trial reports, though the requirements differ. While management software can use similar product data for comparison, software that only transmits data or performs image processing has less clinical relevance.
Many companies also question the applicability of technical standards. Tian Yanfang stated that GB/T17544, a general IT standard, is not fully suitable for medical software. Additionally, security risk analysis based on YY0316, which applies to medical device hardware, is challenging for software registration.
Chi Yongzhen, deputy secretary-general of the China Medical Device Industry Association, noted that software development and use in the medical device industry often occur in separate units. Many manufacturers purchase software from IT companies rather than developing it themselves, leading to complications in registration. As IT companies enter the medical device industry, clear regulations are needed to ensure fair competition.
The SFDA has acknowledged that medical software management is largely unregulated. While many medical software and devices are registered together, the focus has been on hardware. However, with the increasing number of medical software manufacturers and non-embedded software, this area is now receiving more attention. The question remains: should medical software be managed separately, or adapted to the current model? These issues are still under discussion.
In the U.S., the FDA has developed several guidance documents to address software registration. For example, in 2005, the FDA issued a new "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," replacing the 1998 version. This guidance covers all software-related submissions, including those for software-only medical devices. Specific guidelines are also available for different types of software, such as image analysis tools.
Tian Yanfang suggested that China could learn from the FDA’s approach by creating more detailed regulations and guidelines to better assist companies with registration. She recommended clarifying the relationship between the Medical Device Classification Decision Table and the three management categories (I, II, III) to improve classification accuracy.
Currently, the "Beijing High Medical Device Software Product Supervision and Management Regulations (Temporary)" is the only official regulation for medical software in China. While it has been welcomed by many manufacturers, it still requires improvements. Neusoft Digital Medical Systems has conducted extensive research on medical software management and offered suggestions, such as adding classification rules, supplementing the classification table, and allowing self-testing for lower-risk products.
Li Ying emphasized that medical software belongs to both the medical device and IT industries, and cross-sector management is necessary. Clear definitions of overlaps are crucial for future industry development.
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