- Key Elements of the MFDS Safety Guidelines for Mobile Medical Applications
On December 31, 2013, the Ministry of Food and Drug Safety (“MFDS”) issued the “Safety Guidelines for Mobile Medical Applications” (“Guidelines”) which will apply to mobile medical applications intended for medical purposes such as diagnosis or treatment of diseases. The key elements of the Guidelines are as follows.
- Scope of Mobile Medical Apps Subject to Regulation as Medical Devices
The intended use of a mobile medical app determines whether it meets the definition of a medical device under Article 2 of the Medical Devices Act (“MDA”). Under Article 3 of the MDA, the classification of a mobile medical app is determined by its intended use and the degree of its potential risk to human health. In the Guidelines, the MFDS clarifies that the following mobile medical apps are considered medical devices: (a) mobile apps that remotely control medical devices; (b) mobile apps that display, store or analyze medical device data; (c) mobile apps that transform the mobile platform into a medical device by using a sensor or electrode attached to the mobile platform; (d) mobile apps that transform the mobile platform into a medical device by using a sensor within the mobile platform itself; and (e) mobile apps that perform patient-specific analysis and provide patient-specific diagnosis or treatment recommendations. Examples of those mobile apps are identified in the Guidelines.
- Approval/Notification and Quality Requirements
Under Article 6(2) of the MDA, an approval from (or notification to) the MFDS will be required for a mobile medical app that constitutes a medical device. In the approval/notification process, a mobile medical app may be either examined together with another medical device as an accessory to the medical device or examined separately as a separate medical device, depending on its intended use. Moreover, as a mobile platform to run a mobile medical app is an electric appliance, it needs to meet the safety requirements under “Common Criteria and Standards for the Electrical and Mechanical Safety of Medical Devices” (MFDS Notification No.2013-182) and “Common Criteria and Standards for Electromagnetic Safety of Medical Devices” (MFDS Notification No.2013-168). Furthermore, a mobile medical app is software, and as such, it needs to meet the performance requirements under the “Guidelines for Software Validation.” On the other hand, as a mobile medical app inevitably involves collecting, storing and processing personal information, it also needs to meet the requirements to protect the security of personal information under the “Guidelines of Approval and Examination of U-Health Care Medical Devices.”
- Implications of the Guidelines
Even before issuing the Guidelines, the MFDS regulated mobile apps as medical devices if the mobile apps constituted medical devices. However, with the spread of mobile devices and rapid pace of innovation in mobile apps, the MFDS issued the Guidelines which is similar to the “Mobile Medical Applications Guidelines for Industry and Food and Drug Administration Staff” published by the U.S. Food and Drug Administration on September 25, 2013 in recognition of the necessity to regulate mobile apps that constitute medical devices in distinction from mobile apps that are not considered medical device. Examples of mobile medical apps identified in the Guidelines can be used as indicators in determining whether a mobile medical app will be considered a medical device. Meanwhile, under Article 35(1)(ii) of the MDA and Table 7 of Article 35 of the Enforcement Rule of the MDA, if a medical device manufacturer manufactures a medical device without approval/notification, the manufacturer will be subject to administrative measures such as revocation of manufacturing license. In addition, the registration and distribution of a mobile app which is considered a medical device may be suspended under Article 44-7 of the Act on Promotion of Information and Communication Network Utilization and Information Protection. Therefore, mobile medical app manufacturers would need to carefully examine whether their mobile medical apps will be considered medical devices, and how to manage them, from early in the manufacturing process.