Regulation for Health Care Software Programs: Part 3

http://good-hs.jp/

Even if you believe your program is not within the scope of “medical device,” you have to consider the risk that your program might be subject to the act due to the additional modifications.

Additionally, if it turns out that your program has problems on human life, you might need to find any justifiable ground for your business activity. As such, you might need to consider GHS development guideline below.