Regulation for Health Care Software Programs: Part 1

The Law Concerning the Establishment for Pharmaceuticals and Medical Devices is related to software programs in relation to health equipment.  Under the 2014 revision, medical device under Article 2(4) includes programs prescribed in cabinet order for such purposes as: diagnosing programs for disease, medical treatment programs for disease and programs for the prevention of disease.

Such programs were included for the following reasons:  (1) due to telecommunication development and the expansion of smart phones, we can easily foresee that program itself will disseminate rapidly without equipment via the internet etc. , (2) in foreign countries such programs are regulated as medical devices, (3) the traditional procedure, where a set of devices including programs are subject to authorization for each individual update of program, is not practical.

Distribution of programs is also regulated; such regulation includes one for internet distribution.

Under the guideline, where a program does not have any influence on human life and health, even if there are defects in the program, such a program might be excluded the definition of medical device.

For further information, please seek professional advice.