Generally, “electrolyzed water” refers to an aqueous solution obtained by electrolyzing tap water or the like with direct current.
In particular, “electrolytically produced functional water” is an aqueous solution that has acquired reproducible and useful functionality through electrolysis, and reliable scientific evidence regarding the electrolytic treatment and the functionality of the resulting water has been demonstrated.
Various types of electrolyzed water can be generated depending on the electrolysis conditions. Water can be roughly divided into “hygiene control” water, typified by alkaline ionized water, and “potable water”.
Alkaline ionized water is water that is generated from drinking water (drinking water that complies with the Tap Water Quality Standards Directive) through electrolysis using a household water electrolysis device called an “alkaline ionized water device.” Alkaline ionized water meets tap water standards except for the pH range. Alkaline ionized water equipment is classified as equipment/equipment type 83 “medical substance generating equipment” according to the Pharmaceutical Affairs Law.
Currently, there are more than 20 manufacturers of alkaline ionized water devices. According to the Medical Industry Production Movement Statistics (Health Policy Bureau, Ministry of Health, Labor and Welfare), the total annual production of the entire industry is reported to be approximately 300,000 units in recent years, so this device is widely distributed in households. welfare).
Reference: Approval of alkaline ionized water devices as medical devices
There are many devices that process tap water to produce potable water. In order to provide appropriate information to general consumers and promote the healthy growth of the alkaline ionized water device industry, the basic items for the manufacture and sale of devices approved as medical devices are as follows:
1.Subject
Functional water production equipment for household drinking water (not including industrial equipment mainly for food production)
Structure:
Structures compatible with Type 83 electrical appliances: “Medical substance generating devices (1298 or 1299)” issued in 2004 by Ministry of Health, Labor and Welfare Notification No. 298, or structures with the same structure and shape as previously approved products. objects (including products with very similar structures)
Intended use
Products with the same purpose and method of use as approved products, or products that are recognized to have the same purpose as approved products (including products with approved uses; medical devices based on structure and shape)
Term (name)
Products using the following names that can be recognized as approved medical devices:
・Products with the same name as the certified sales name of already approved products (alkaline ionized water equipment, ionized water generator, electrolyzed reduced water generator, etc.)
・Things that use general names in the Ministry of Health, Labor and Welfare directives or those defined by the Japanese Industrial Standards (JIS-T 2004) (medical substance generators, flow-type electrolyzed water generators, household water electrolyzers, etc.)
・Products with names that may cause misunderstanding regarding medical devices (alkaline ionized water, electrolyzed reduced water, etc.)
Products that fall under items 1 to 4 above but have not been approved or certified as medical devices will not be handled by members of this association. (We have no opinion on the safety or effectiveness of the product.) Please pay attention to the product name and whether there is an approval/certification number as a medical device.