KFDA* announced that the Safety Guidelines for Mobile Medical Applications should be applied on December 31, 2013. The gist of guideline is summarized as follows:
1. Subject App
All mobile platforms including smartphone, tablet PC and smart watch for the medical use may be subject to the guidelines. But the scope shall be limited to the Apps whose use meets the definition of a medical device under Article 2 of the Medical Device Act.
According to KFDA, the guidelines would be applied to the apps below:
A. Apps that remotely control medical devices
B. Apps that display, store or analyze data acquired from medical devices
C. Apps that transform the mobile platform into a medical device by using attachments such as electrodes or sensors
D. Apps that act as a medical device by using sensors within the mobile platform
E. Apps that perform patient-specific analysis and provide diagnosis or treatment recommendations.
2. Required Marketing Approval
Before launching a mobile medical app, the publisher shall obtain market approval from KFDA. It is required as like a medical device. It must meet the safety requirements of KFDA guidelines; i.e., Criteria and Standards for the Electrical and Mechanical Safety of Medical Devices, Criteria and Standards for Electromagnetic Safety of Medical Devices, Standard of Medical Device Software Validation, etc.
Furthermore, the applicant must meet the guidelines about the activities to collect, store and process personal medical information. He or she must protect personal information properly pursuant to the KFDA Guidelines of Approval and Examination of U-Healthcare Medical Devices.
* KFDA officially changed its name to the Ministry of Food and Drug Safety (MFDS) in March 2013.
