Acidic oxidation potential water generator is through the equipment to make hypochlorite disinfectant solution, used for medical equipment, object surface. Skin mucous membrane, environment and other disinfection products. Acidic oxidation potential water generator since entering our country has been according to the disinfection equipment to manage, need to obtain the National Health Commission of the disinfection equipment health administrative license can be sold, in 2013 the People's Republic of China in order to simplify the administrative examination and approval of the National Health and Family Planning Commission issued the "on the cancellation of the decentralization of some of the administrative examination and approval of the disinfection of products and products related to water bulletin (2013 No. 7)" after the "acidic oxidation potential water generator". (No. 7)" after the acidic oxidation potential water generator will not have to health permit approval, is the implementation of the online filing system. But disinfection products on the market before the "national disinfection products online filing information service platform" for the record can be sold and used. Acidic oxidation potential water generation equipment according to the effectiveness and safety of the product can be divided into one category and two categories. One is a high level of disinfection products, the second is the level of disinfection products. Before the record entrusted to the national accredited testing organizations to test and do health and safety evaluation report submitted to the Health Commission's online filing agency for approval for the record as long as the online filing system for the record can be successful sales and use.
In 2004, the State Food and Drug Administration Division of Medical Devices issued a notice "on the intestinal hydrotherapy machine and other products classified as defined in the notice" State Food and Drug Administration Mech (2004) No. 433 in the acidic oxidation potential water generation equipment can also be used as a medical device class II to manage. From now on can also be in accordance with the second class of medical devices to register and can be medical devices to sales and use.
The Chinese people **** and the State National Health and Family Planning Commission under the two departments: Health Supervision Center and the Food and Drug Administration can manage the sale and use of acidic oxidation potential water generator, the use of its purpose is disinfection. Before the product is listed on the market must apply for the record of disinfection equipment or medical device registration certificate, with one of them can be. Sterilization equipment for the record cycle is relatively short, the scope of application is relatively wide, the cost of the record is relatively low, but to do the medical device registration certificate review cycle is relatively long, the scope of application is only the disinfection of medical devices, the disadvantages of the registration fee is relatively high, so most manufacturers to disinfecting equipment for the record sales. Domestic currently only a dozen with medical device registration certificate.
In short, regardless of whether the disinfection equipment for the record or medical device registration certificate, as long as one or both have can be sold and used.