Water ionizers a Medical Device? ISO 13485?
At least in Japan and Korea, water ionizers are considered a medical device. Part of the reason is simply because of strict governmental regulations that require instruments, apparatuses, and devices (which are designed for human use in a therapeutic way) to verify their quality, security, and safety.
Some marketers have claimed that their water ionizer is the only one with the ISO 13485 certification, but this is not true. In order to obtain ISO 13485 certification, a company needs to follow specified systemic requirements and pay a fee of around $40,000 dollars.
The history of medical approval for these water ionizers is quite interesting. There are a lot of facts that most people in the industry are simply unaware of. The page Alkaline Ionized Water: History and Medical Approval, found under Core Information, explains much of this in concise detail.