Interpretation of the Guiding Principles for Technical Review of Mobile Medical Device Registration

Medicine Network January 3 , In order to implement the relevant requirements of the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Devices ( Office Word ( 2017) No42 ) , to promote the innovation and development of the medical device industry , and to strengthen the supervision and guidance of the registration of mobile medical device products , the State Food and Drug Administration formulated and promulgated the Guiding Principles for Technical Review of Mobile Medical Device Registration ( hereinafter referred to as the Guiding Principles )Mobile medical devices, as a combination of mobile computing technology and medical devices, involve network security, cloud computing, big data and other technical fieldsThese Guidelines are intended to guide applicants in submitting mobile medical device registration declarations, while regulating the technical review requirements for mobile medical devicesThese Guidelines are based on the requirements of the Cyber Security Law of the People's Republic of China, the Regulation solely on Medical Devices, the relevant regulations on health and family planning, the relevant standards for medical devices, and the relevant standards for information security (cloud computing, big data, mobile smart terminals), and draw on the relevant requirements of FDA guidelines, EU documents and IMDRF documentsThese Guidelines should be used in conjunction with the Guidelines for Technical Review of Medical Device Software Registration, The Guidelines for Technical Review of Medical Device Cybersecurity Registration, and the Technical Review Guidelines for The Registration of Medical Device Products(1) The scope of applicationguidelines apply to the registration declaration of mobile medical devices, including category II and third category medical device products(ii) Definition of mobile medical devices
"mobile medical devices" as defined in these guidelines refers to devices and/or software that use noninvasive "mobile computing terminals" to achieve one or more medical purposes, which are divided into three categories: mobile medical devices, mobile independent software and mobile medical accessoriesmobile computing deviceor or software that meets the definition of a medical device is a mobile medical devicedefinition of "mobile computing terminal" refers to the use of personal mobile computing technology product terminals, including universal terminals and dedicated terminals, can be divided into handheld, wearable and hybrid formsAt the same time, this guideline makes it clear that mobile medical devices are a combination of mobile computing technology and medical devices, which differ from "mobile medical devices" (see GB 9706.1-2007 definition)This Guideline applies to products that use handheld, wearable or hybrid commercial and home-made medical mobile computing terminals, and defines the technical considerations of mobile, which are more extensive and more specific than those of the United States and the European Union(3) The basic principle sandmobile medical device as a combination of mobile computing technology and medical device, its regulatory requirements in addition to the requirements of traditional medical devices need to consider the characteristics and risks of mobile computing technologyFocus on the risks introduced by medical devices using mobile computing technology and their controlsapplicants should manage risk according to the type of mobile medical device, intended use, environment and core functions, and the type and characteristics of the mobile computing terminal used to ensure the safety and effectiveness of mobile medical devices(4) Technical considerations
mobile medical devices can often be used to realize or partially realize the functions and uses of traditional medical devices, so its performance indicators may refer to the requirements of equivalent traditional medical devices, and should be matched with their intended use, use environment and core functions to meet clinical requirementsCommon common technical issues include, but are not limited to, network security capabilities, display limits, ambient photoimaging, battery capacity limitations, cloud computing services, and so on(5) registration declaration information requirements
in view of the wide variety of mobile medical device products, the use of a variety of forms, clinical requirements and performance indicators vary widely, it is difficult to unify the registration declaration information requirementsThese guidelines require applicants to submit appropriate registration filings to demonstrate the safety and efficacy of the product based on the type of mobile medical device used, the characteristics of the mobile computing terminal used, and the clinical requirements(1) Regarding the judgment of mobile medical devices and mobile health electronic products
mobile medical devices and mobileelectronic products are difficult to be clearly divided by definition, where mobile computing devices or software that conform to the definition of medical devices belong to mobile medical devices These Guidelines recommend a comprehensive determination in the context of the intended use, target population and core functions of mobile computing equipment or software, and, if necessary, applicants should apply for a classification definition of medical devices (ii) The use of cloud computing
mobile medical devices in combination with cloud computing is becoming more common, and this guideline defines the technical requirements for cloud computing services from the perspective of off-the-shelf software and vendors At the same time, these guidelines require applicants to continuously track the provisions of national laws and departmental regulations related to network security, cloud computing, and big data, to ensure the network security of mobile medical device products themselves, and to protect patient privacy In addition, cloud computing, big data, mobile smart terminal related countries are being developed and released, the guidelines refer to the set out the corresponding standards for manufacturers to use (iii) On the relationship between wearable technology in the computer field, the relationship between mobile computing technology and wearable computing technology has not been determined, one view is that wearable computing technology is an important branch of mobile computing technology, and the other view that wearable computing technology is the next generation of mobile computing technology From a regulatory perspective, the mobile computing technology described in these guidelines includes wearable computing technology At present, wearable mobile medical devices are mainly wearable products, wearable products are fewer, and the use of flexible computing technology wearable mobile medical devices have not yet been available Taking into account technology trends, these guidelines specify that mobile medical devices using flexible computing technology should provide verification data on availability and reliability in addition to general requirements, and will further refine the requirements in the future in the light of product conditions and technology trends.