Guideline For Technical Review Of Mobile Medical Device Registration
2021-06-22
Annex This guideline consists of general requirements for mobile medical device. Applicants should determine whether the specific content in the guideline is applicable or not, and explain the reasons for inapplicable contents, and enrich or refine the contents of the data for registration and declaration according to the specific characteristics of the product. This guideline is a guide for applicants and reviewers. It does not deal with administrative matters such as registration approval. It is also not enforced as a statute of law. This guideline is a guiding document for applicants and review personnel. It does not involve administrative matters such as registration and review, nor is it enforced as laws and regulations. Other methods that meet the regulatory requirements can also be used, but detailed study data and verification data should be provided. The guideline should be used in compliance with relevant This guideline is intended to guide registered applicants in the preparation for data for registration and declaration of mobile medical device, and provide reference for technical review departments. Medical Device Registration Guideline for Technical Review of Mobile —— 2 — laws and regulations. This guideline is formulated based on the current regulations, standard system and cognitive level. With the continuous perfection of regulations and standard systems, and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in time. This guideline should be used by combining with the requirements of the “Guideline for Technical Review of Medical Device Software Registration” (hereinafter referred to as the Software Guideline), the “Guideline for Technical Review of Medical Device Network Security Registration” (hereinafter referred to as the Network Security Guidance) and guidelines for related medical device products. This guideline is a general guideline for mobile medical devices, and other guidelines involving mobile medical devices can be adjusted, modified and improved on the basis of this guideline. I. Scope This guideline applies to the registration and declaration of mobile medical devices, including the second and third types of medical device products. II. Mobile medical device (I) Definition of mobile medical device The “mobile medical device” as defined in this guideline is device and/or software that uses non-invasive “mobile computing — 3 —— terminal” for one or more medical purposes1 , in which the “mobile computing terminal” refers to a mobile computing technology product terminal for personal use, including general (commercial off-the-shelf) terminals and dedicated (self-made medical) terminals, whose use forms can be divided into handheld (such as tablet computers, portable computers, smart phones, etc.), wearable 2
(such as smart glasses, smart watches, etc.) and hybrid (combination of handheld and wearable). Mobile medical devices contain medical device software or are independent software themselves. Mobile and wearable medical devices that do not include medical device software are not mobile medical devices. Medical devices for implantation and intrusion are not included in the scope of mobile medical devices for their particularity, but the use of “mobile computing terminal” should take into account the applicable requirements of this guideline. (II) Types of mobile medical devices
Mobile medical device Mobile medical device refers to a device that uses general or dedicated mobile computing terminals for one or more medical purposes. Such products use the built-in or external sensors, displays and other components of mobile computing terminals to achieve the 1 Adapted from the definition of independent software by the IMDRF SaMD working group. 2 In the field of computer, the relationship between mobile computing technology and wearable computing technology is inconclusive. From the perspective of supervision, the mobile computing technology described in this guideline includes wearable computing technology. —— 4 — intended purpose, usually used to achieve or partially achieve the functions and purposes of equivalent traditional medical devices.
Mobile independent software Mobile independent software refers to independent software that uses general or dedicated mobile computing terminals (including retrofits) for one or more medical purposes. Such products have the same expected purpose as traditional independent software, and the main difference lies in the software operating environment.
Mobile medical accessory Mobile medical accessory is a device or software that uses general or dedicated mobile computing terminals to control the operation of medical device (ie, control type) or exchange electronic data with medical device (ie, data type). As a component of a medical device product, the controlled mobile medical accessory can not achieve the intended purpose alone, and should be registered with the medical device product as a whole. Data-type mobile medical accessories can be registered with the medical device product as a whole, or separately (in this case they are regarded as mobile medical device or mobile independent software). (III) Principle for determining mobile medical devices There is no clear boundary between mobile medical devices and mobile health electronic products. Mobile computing devices or software meeting the definition of medical devices all belong to — 5 —— mobile medical devices. Applicants shall determine whether the mobile computing device or software meets the definition of medical device according to its intended purpose, and, if necessary, apply for classification of the medical device. In general, mobile computing devices or software intended for health management, target at healthy groups, record and calculate health information do not have a medical purpose and do not belong to mobile medical devices; while those intended for disease management, target at medical staff and patients, control and drive medical devices, handle, analyze and monitor medical data/images have medical purposes and are mobile medical devices3 . For example, mobile computing devices or software intended for assisting physicians in disease diagnosis and treatment are mobile medical devices, mobile computing devices or software intended for patient rehabilitation training, bariatric therapy, autism therapy, etc., are mobile medical devices, while mobile computing devices or software intended for healthy people’s fitness, weight control, lifestyle records, etc., are not mobile medical devices. III. Basic principles As a combination of mobile computing technology and medical devices, the monitoring of mobile medical devices needs to comprehensively consider the characteristics and risks of mobile computing technology in addition to the requirements of traditional 3 Adapted from considerations of the Independent Software Risk Framework by the IMDRF SaMD Working Group. —— 6 — medical devices. This guideline focuses on the risks introduced by the use of mobile computing technology in medical devices and their controls. Applicants shall conduct risk manage according to the type, intended purpose, use environment and core functions of mobile medical device and the type and characteristics of the mobile computing terminal used, to ensure the safety and effectiveness of mobile medical devices. The risk management of mobile medical devices should comprehensively consider the risks (such as electrical safety, biocompatibility, etc.) of the equivalent traditional medical devices and the risks of the mobile computing terminals used. The risk management of mobile independent software should comprehensively consider the risks of traditional independent software and the mobile computing terminal used. The risk management of the controlled mobile medical accessory should be integrated with the medical device product for overall consideration. The risk management of the data type mobile medical accessory should refer to the mobile medical device or mobile independent software. Mobile medical devices used by patients (especially in home environments) should also consider the risk in the link of using. The risks of mobile computing terminals are mainly manifested as small display size, low resolution, low brightness, great effect by — 7 —— ambient light, small battery capacity and data transmission distortion, which may not meet all the clinical requirements. Compared with dedicated terminals, general terminals are not intended for medical purposes, and the performance index may not meet all the clinical requirements. In addition, the software operating environment of general terminals may be uncontrolled, which may result in unintended product operation and relatively high risk in use. Therefore, applicants should select a suitable mobile computing terminal and ensure that the mobile computing terminal used meets all clinical requirements. Mobile medical devices often have networking function for electronic data exchange or remote control, and its combination with cloud computing and big data is increasingly common. Therefore, applicants should keep track of the national laws, regulations and department rules related to network security, cloud computing and big data as well as the requirements of national standards and industry standards, so as to ensure the network security of mobile medical device products and protect the privacy of patients. There are a variety of mobile medical device products, with various use forms. There is a great difference between clinical requirements and performance indicators, and it is difficult to unify requirements for data of registration and declaration. Applicants shall submit the corresponding data of registration and declaration according to the type of the mobile medical device, the —— 8 — characteristics of the mobile computing terminal used and the clinical requirements to prove the safety and effectiveness of the product.
