Association of Alkaline Ionized Water Apparatus

In general, "electrolyzed water" refers to the aqueous solution obtained after electrolytic treatment of tap water, etc. using direct current.
In particular, "electrolytically-generated functional water" is the aqueous solutions which acquired reproducible and useful functions by electrolysis, and for which reliable scientific evidences regarding the electrolytic treatment and the functions of resulting water have been shown.
Various types of electrolyzed water can be generated depending on the electrolysis conditions. They can be roughly classified into "one for hygienic management" and "the other for drinking purpose" represented by alkaline ionized water.
Alkaline ionized water refers to water generated from drinkable water (potable water conforming to the directives of the tap water quality standards) by electrolysis using water electrolyzer for home-use called "alkaline ionized water apparatus". Alkaline ionized water meets the tap water standards except for pH range. Alkaline ionized water apparatus is classified as the appliance/device Type 83 "Medical substance generating apparatus" under the directives of the Pharmaceutical Affairs Law.
There are currently more than 20 manufacturers of alkaline ionized water apparatus. The apparatus is being widely distributed in homes, since the total annual production quantity of the entire industry is reported as approximately 300,000 units in recent years, according to the medical industry production movement statistics (the Health Policy Bureau of the Ministry of Health, Labour and Welfare).

Reference: About approval of alkaline ionized water apparatus as a medical apparatus

There are many kinds of apparatus that treat tap water to generate water for drinking. In order to supply appropriate information to general consumers and to promote the sound growth of the alkaline ionized water apparatus industry, basic items for the manufacture and sales of the apparatus approved as medical device will be as follows:

1. Subject
   Apparatus for home-use generating functional water for drinking (Industrial-use apparatus mainly for food preparation is not be included.)
2. Structure
   Structures which conform to Type 83 appliance devices: "Medical substance generation apparatus (1298 or 1299)" issued in 2004 by the Ministry of Health, Labour and Welfare Notification No. 298, or structures which have the same structure and shape as previously approved products (including products with very similar structures)
3. Purpose of use
   Products for which the purpose of use as well as the use method are the same as approved products, or products which are recognized as having a purpose of use equivalent to that of approved products (including products which can be recognized as having purposes of use as medical apparatus based on the structure and shape)
4. Terminology (Name)
   Products which use the following names which can be recognized as being medical apparatus approved: 　
   • Products which use the same name as the approved sales name for previously approved products (alkaline ionized water apparatus, ionized water generator, electrolytic reduced water generator, etc.)
   　
   • Products which use the general name in Ministry of Health, Labour and Welfare directives or defined in Japanese Industrial Standards (JIS-T 2004) (medical substance generator, flow-type electrolyzed water generator, water electrolyzer for home-use, etc.)
   　
   • Products which use names that could give misunderstanding about medical apparatus (alkaline ionized water, electrolytic reducing water, etc.)

Products which have not received approval or certification as the medical apparatus in spite of that the above items 1 to 4 are applicable, are not dealt by the members of this association. (Please note that we have no opinion regarding the safety, effectiveness, etc. of such products.) Please be careful regarding the name and whether or not a product has an approval and certification number as a medical apparatus.