Interpretation of Guiding Principles for Mobile Medical Device Registration Technology Review

January 3 In order to implement the relevant requirements of "Opinions on Deepening the Innovation of Examination and Approval System for Drug Evaluation and Innovation in Medical Devices" (Ting Zi [2017] No. 42), to promote the innovation and development of the medical device industry and to strengthen the mobile medical devices Product registration supervision and guidance, the State Food and Drug Administration formulated and promulgated the "Mobile Medical Device Registration Technical Review Guidelines" (hereinafter referred to as the guidelines).

As a combination of mobile computing technology and medical devices, mobile medical devices are involved in the technical fields of network security, cloud computing and big data.

This guideline is intended to guide applicants in filing mobile application registration filings and to standardize the technical review requirements for mobile medical devices.

The guidelines are mainly based on the "Network Security Law of the People's Republic of China", regulations on medical device regulation, relevant regulations on health planning, medical device standards and information security standards (cloud computing, big data, mobile intelligent terminal) requirements At the same time, the reference draws on the relevant requirements of the FDA guidelines, EU documents and IMDRF documents.

This guideline should be used in conjunction with the Guiding Principles for Medical Device Software Registration Technology Review, Medical Device Network Security Registration Technology Review Guidelines and related medical device product registration technical review guidelines.

(A) the scope of application

Guiding principles applicable to the registration of mobile medical devices, including the second category, the third category of medical device products.

(B) the definition of mobile medical devices

The term "mobile medical device" as defined in these Guidelines refers to the devices and / or software that implement one or more medical applications using a non-invasive 'mobile computing terminal' and is divided into three categories: mobile medical device, mobile independent software and mobile medical accessory class.

Where the medical device definition of mobile computing devices or software are mobile medical devices.

The term "mobile computing terminal" as used in the definition refers to a mobile computing technology product terminal for personal use, including general purpose terminals and special purpose terminals, and can be divided into handheld, wearable and hybrid types, and the present guidelines clearly define mobile medical devices Is a combination of mobile computing technology and medical devices that differs from the 'mobile medical devices' (see GB 9706.1-2007).

This guideline applies to products that employ hand-held, wearable, or hybrid commercial off-the-shelf and home-made medical mobile computing devices that specify movement medical instruments The technical considerations, compared with the United States, the EU, a wider scope of application, technical requirements are more specific.

(Three) the basic principle

As a combination of mobile computing technology and medical devices, mobile medical devices need to consider the characteristics and risks of mobile computing technology in addition to the requirements of traditional medical devices, focusing on the risks introduced by mobile computing technology in medical devices and Its control measures.

The applicant shall manage the risk and ensure the safety and effectiveness of the mobile medical device according to the type of the mobile medical device, the intended use, the use environment and core functions, and the type and characteristics of the mobile computing terminal used.

(D) technical considerations

Mobile medical devices are usually used to realize or partially realize the functions and uses of traditional medical devices. Therefore, their performance indexes can refer to the requirements of equivalent traditional medical devices and should match the intended use, environment of use and core functions to meet clinical requirements Common common technical issues include, but are not limited to, network security capabilities, display limitations, ambient light images, battery capacity limitations, cloud computing services, and more.

(E) registration declaration information requirements

In view of the wide range of mobile medical device products, the use of various forms, clinical requirements and performance indicators vary widely, it is difficult to unify the registration declaration data requirements.The guidelines require the applicant based on the type of mobile medical devices, the characteristics of mobile computing terminals and clinical requirements Submit the corresponding registration declaration data to prove the safety and effectiveness of the product.

(1) Judgment on mobile medical devices and mobile health electronic products

Mobile Medical Devices and Mobile health Electronic products are difficult to define clearly, and any mobile computing device or software that meets the definition of a medical device is a mobile medical device.

The guidelines recommend combining the intended use of the mobile computing device or software, the target population and core functions to make a comprehensive judgment, and where necessary, the applicant should apply for medical device classification.

(B) on the cloud computing

The combination of mobile medical devices and cloud computing is becoming more commonplace, and these guidelines clarify the technical requirements for cloud computing services from off-the-shelf software and vendor perspectives, and at the same time, the guidelines require applicants to keep track of network security, cloud computing , Big data related to national laws Regulations And departmental rules and regulations to ensure that mobile medical device products own network security and protect patient privacy.In addition, cloud computing, big data, mobile intelligent terminal-related countries standard Is being formulated and released, the guidelines for reference literature The corresponding standards are listed for reference by the manufacturer.

(C) on wearable technology

In the computer field, the relationship between mobile computing technology and wearable computing technology has not yet been finalized. One view holds that wearable computing technology is an important branch of mobile computing technology. Another view is that wearable computing technology is the next generation of mobile computing technology. As a starting point, the mobile computing technology described in this guideline includes wearable computing technology.

At present, wearable mobile medical devices are mainly wearable products, wearable products less, and the use of flexible computing technology wearable mobile medical devices no product listing.Considering the technology trends, the guidelines explicitly the use of flexible computing In addition to the general requirements for mobile medical devices, the technical mobile medical devices should also provide verifications of availability and reliability. In the future, the mobile medical devices will be further refined in the light of product conditions and technological trends.