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Understanding Controlled Medical Devices: A Guide to Choosing Alkaline Water Ionizers in India

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  In recent years, the popularity of Alkaline water ionizers and Hydrogen Plus alkaline water Ionizers has surged in India, driven by their claimed health benefits such as aiding digestion, reducing acid reflux, and neutralizing free radicals. However, a growing concern is the misleading claims made by many locally assembled and Chinese/Korean brands, which confuse customers with terms like “medical device” or “medical ISO certification.” This article aims to educate readers about Controlled Medical Device certification in Japan and why it is crucial when choosing an hydrogen plus alkaline water ionizer. What Is the Controlled Medical Device Category? In Japan, the Controlled Medical Device category, or “Kanri Iryo Kiki” ( 管理医療機器 ), is a regulatory classification for devices that offer health benefits but come with moderate risks requiring strict safety measures. It is governed by the Pharmaceuticals and Medical Devices Agency (PMDA) under the Ministry of Health, Labour and Wel...