Guiding principles for technical review of mobile medical device registration
Last Update: 2020-06-19
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In order to strengthen the supervision and guidance of the registration of medical devices and further improve the quality of registration and examination, the State Food and drug administration has formulated the guiding principles for technical examination of mobile medical device registration (see Annex), which are hereby promulgated< br / > < br / >< br / > < br / >< br / > < br / > this guiding principle is a general requirement for mobile medical devicesThe applicant shall determine whether the contents are applicable according to the specific characteristics of the productIf not, the applicant shall explain the reasons and enrich and refine the contents of the registration application materials according to the specific characteristics of the product< br / >This guideline should be used in accordance with relevant regulations< br / > < br / > this guiding principle is formulated under the current laws and regulations, standard system and current cognitive levelWith the continuous improvement of laws and regulations, standard system and the continuous development of science and technology, the relevant contents of this guiding principle will be adjusted in due time< br / > < br / > the guiding principles shall be used in combination with the requirements of guiding principles for technical review of medical device software registration (hereinafter referred to as the guiding principles for software), guiding principles for technical review of medical device network security registration (hereinafter referred to as the guiding principles for network security) and relevant guiding principles for medical device productsThis guiding principle is a general guiding principle for mobile medical devicesOther guiding principles involving mobile medical devices can be adjusted, modified and improved on the basis of this guiding principle< br / > < br / > < br / > these guidelines are applicable to the registration and declaration of mobile medical devices, including the second and third categories of medical device products< br / >"Mobile computing terminal" refers to the terminal of mobile computing technology products for personal use, including general (commercial off the shelf) terminal and special (self-made medical) terminal, The use forms can be divided into handheld (such as tablet computer, portable computer, smart phone, etc.), wearable (such as smart glasses, smart watch, etc.) and hybrid (combination of handheld and wearable)< br / > < br / > mobile medical devices contain medical device software or are independent softwareMobile and wearable medical devices without medical device software do not belong to mobile medical devices< br / >< br / >This kind of products use the sensor, display screen and other components of mobile computing terminal to achieve the intended use, and can be used to achieve or partially realize the functions and uses of equivalent traditional medical devices< br / > < br / > 2Mobile independent software < br / >Compared with the traditional independent software, this kind of product has the same intended use, and the main difference lies in the different software operating environment< br / >As an integral part of the medical device product, the controlled mobile medical accessory cannot achieve its intended use alone, and shall be registered with the medical device product as a wholeData based mobile medical accessories can be registered with the medical device product as a whole or separately (at this time, it is regarded as mobile medical device or mobile independent software)There is no clear demarcation line between mobile medical devices and mobile electronic productsAll mobile computing devices or software that meet the definition of medical devices belong to mobile medical devicesThe applicant shall determine whether the mobile computing device or software conforms to the definition of medical device according to its intended use, and shall apply for the classification definition of medical device when necessary< br / > < br / > generally, the mobile computing devices or software that are expected to be used for health management, the target population is the healthy population, and the health information is recorded do not have medical purpose, It does not belong to mobile medical devices; however, it belongs to mobile medical devices that are expected to be used for disease management, target population for medical staff and patients, control driven medical devices, processing, analysis and monitoring of medical data / images of mobile computing devices or software with medical purposes< br / > < br / > for example, mobile computing devices or software intended to assist doctors in disease diagnosis and treatment belong to mobile medical devices, while mobile computing devices or software intended to be used in patient rehabilitation training, obesity treatment, autism treatment belong to mobile medical devices, However, the mobile computing devices or software that are expected to be used for exercise and fitness, weight control, lifestyle records, etcof healthy people are not mobile medical devices < br / > < br / > < br / > as a combination of mobile computing technology and medical devices, the regulatory requirements of mobile medical devices need to consider not only the requirements of traditional medical devices, but also the characteristics and risks of mobile computing technology This guideline focuses on the risks and control measures of medical devices using mobile computing technology < br / > < br / > the applicant shall conduct risk management according to the type, intended use, use environment and core functions of the mobile medical device as well as the type and characteristics of the mobile computing terminal used to ensure the safety and effectiveness of the mobile medical device < br / >, The risk management of the controlled mobile medical accessories shall be considered in combination with the medical device products The risk management of the data mobile medical accessories shall refer to the situation of the mobile medical devices or mobile independent software The risk of using mobile medical devices used by patients (especially in the home environment) should also be considered < br / > < br / > the risks of mobile computing terminals mainly include small screen size, low resolution, low brightness, large impact by ambient light, small battery capacity, data transmission distortion, etc., which may not meet all the clinical requirements Compared with the special terminal, the general terminal is not designed for medical purpose, and its performance index may not meet all clinical requirements At the same time, the software operating environment of the general terminal is usually uncontrolled, which may lead to unexpected work of the product and relatively high risk of use Therefore, the applicant should select a suitable mobile computing terminal and ensure that the mobile computing terminal can meet all the clinical requirements < br / > < br / > mobile medical devices usually have the function of network connection for electronic data exchange or remote control, and are increasingly used in combination with cloud computing and big data Therefore, the applicant shall continuously follow up the provisions of national laws and regulations and departmental regulations 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 < br / > The applicant shall submit the corresponding registration application materials according to the type of mobile medical device, the characteristics of the mobile computing terminal used and the clinical requirements to prove the safety and effectiveness of the product < br / > Common technical problems include but are not limited to: < br / > < br / > (I) network security capability < br / > < br / > mobile medical devices usually have network connection function for electronic data exchange or remote control, which has network security risk Different types of mobile medical devices require different network security capabilities Therefore, the applicant should clarify the requirements of the product on the network security capability according to the network security guidelines, and provide verification data < br / > < br / > for example, the mobile image processing software intended for diagnosis should have the function of ensuring the unavailability of health data For example, the software can automatically clear the health data downloaded to the local after the medical staff exits the login, or use encryption technology to ensure that the health data downloaded to the local area is not available The verification data should include the corresponding performance verification data < br / > < br / > Therefore, the applicant shall determine the technical requirements (such as screen size, resolution, brightness, etc.) and determination basis of the display screen used in the product according to the type, intended use, use environment and core functions of the mobile medical device, and provide verification data (including clinical evaluation data if necessary) < br / > < br / > the technical requirements for display screen of mobile medical devices and control mobile medical accessories can refer to the corresponding requirements of equivalent traditional medical devices, such as standards, guidelines, etc The technical requirements of mobile independent software and data-based mobile medical accessories for display screen can refer to the requirements of traditional independent software < br / > < br / > for example, the expected mobile image processing software for diagnosis should clarify the minimum size, minimum resolution and minimum brightness of the display screen used by the mobile computing terminal as well as the determination basis Since there is no consensus in the industry at present, the verification data should include performance verification data and clinical evaluation data < br / > < br / > (III) the use environment of mobile medical devices is easy to change due to the influence of ambient light The change of ambient light may lead to misdiagnosis and miscalculation of medical staff, resulting in corresponding risks The types of mobile medical devices are different
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