This guideline applies to the application registration of class II and III mobile medical devices.
2. Mobile Medical Device
(1) Definition of Mobile Medical Device
A “mobile medical device” in this guideline refers to the use of a non-invasive “mobile computing terminal” to achieve one or more medical uses of a device and/or software . “Mobile computing terminal” refers to the personally used terminals of mobile technology products, including general (commercial off-the-shelf) terminals and dedicated (self-made medical) terminals, within the form of hand-held (such as tablets, laptops, smartphones, etc.), wearable (such as smart glasses, smart watches, etc.) and hybrid (combination of hand-held and wearable).
A mobile medical device contains software or be software itself. Medical devices that are mobile and wearable, which do not contain software, shall not be included into the scope of mobile medical device.
(2) Categories of Mobile Medical Device
A. Mobile Medical Device
Mobile medical device refers to the use of general or dedicated mobile computing terminals to achieve one or more medical purposes. Such products use self-contained or external sensors, display, and other components to achieve the intended use, which are usually used to achieve or partially achieve equivalent functions of traditional medical devices.
B. Mobile Stand-Alone Software
Mobile independent software refers to the software using mobile computing terminals to achieve one or more medical purposes. The main difference between mobile software and traditional software is the operating environment.
C. Mobile Medical Accessory
Mobile medical accessories control the operation of medical devices or electronic data interchange with devices using general or dedicated mobile computing terminals. As a component of a mobile medical device, the control-type accessory cannot realize the indication independently, thus should be registered as part of the mobile medical device. A data-type accessory can be registered independently when it is regarded as an independent mobile software or device.
(3) Decision Principles of Mobile Medical Devices
In general, mobile computing equipment or software used for health management or health information collection targeting healthy people shall not be regarded as mobile medical device. Mobile computing device or software that are intended to be used for disease management by healthcare professionals for medical purposes shall be regarded as mobile medical device.
3. Technical Considerations
The most common technical considerations for mobile medical devices include, but are not limited to:
(1) Cyber Security
Different types of mobile medical devices have different requirements for cyber security. Applicants shall provide supporting materials according to cyber security guideline.
(2) Display Screen Requirements
Applicants shall meet the display screen requirements according to the product’s type, indications, environment, and core functions.
(3) Environmental Light Interference
Different types of mobile medical devices have different requirements for environmental light anti-interference abilities. Therefore, applicants shall specify their product’s anti-interference ability based on the product type, indications, environment, and core functions.
(4) Battery Capacity
Different types of mobile medical devices have different battery capacities. Therefore, the applicant shall identify the product’s battery capacity according to the type, indication, environment and core function of the mobile medical device product, and provide verification data to prove that battery endurance can meet clinical requirements.
(5) Cloud Computing Service
For mobile medical devices using cloud computing services, applicants should provide relevant registration information, including basic information (cloud name and configuration, cloud service provider name, residence and qualification), technical requirements (service mode, deployment mode, core functions, data interface, cyber security capabilities), risk management, validation and confirmation, maintenance plan, and quality agreement with cloud service provider.
4. General Registration Application Materials
(1) Mobile Medical Device
Applicants shall refer to this guideline, related traditional medical device guidelines, software guidelines, and cyber security guidelines to prepare registration materials.
(2) Mobile Stand-Alone Software
Applicants shall refer to this guideline, related traditional stand-alone software guideline, software guideline, and cyber security guidelines to prepare registration materials.
(3) Mobile Medical Accessory
A control-type accessory shall be registered with a host mobile medical device. Applicants shall provide registration materials for mobile medical accessory in the host mobile medical device registration application.
Applicant shall refer to the registration requirements of mobile stand-alone software and mobile medical device for independent mobile medical accessory.