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The draft document of Methods of Field Monitoring for Disinfection Products was recently released for public consultation. The Methods was developed to serve as the technical foundation on which standardization of production process management of Type I and Type II disinfection products would be built, as well as the reference documents for authorities to carry out law enforcement activities.
China no longer requires administrative licensing for producing disinfection products, unless new materials, new processes and technologies, or new sterilization mechanisms are applied. Disinfection products already on the market, including disinfectants and disinfection devices, are subject to regulatory classification according to usage and risk level. Type I disinfection products rank the top in terms of safety risks, while Type II and Type III correspond to medium risks and low risks respectively. Type I and Type II products are subject to pre-market safety evaluation and the files are recorded by provincial Health and Family Planning Commissions.
In addition to pre-market evaluation, field monitoring is of vital importance to ensure product safety, particularly after the cancellation of the administrative licensing. During field monitoring, the official inspector samples the products, supervises how a manufacturer’s self-inspection system works and reviews the self-inspection results. Unlike the on-site inspections which focus on the qualification of the manufacturer, production conditions, techniques, processes, and raw materials, the draft Methods provides a solution to determine the quality of the final products directly, which saves time and money compared to sending samples to accredited test facilities and is also more reliable compared with the self-testing results supplied by manufacturers.
The draft Methods requires field monitoring targeting Type I and Type II disinfection products at least twice a year followed by filing of results. The required tests include those on physics/chemical germicidal factor intensity, chemical (biological) indicator, pH value, content of the active ingredients, net content, package/container impermeability, etc. Manufacturers must pass the monitoring program or make effective improvements to be qualified for market access.
The final document will be published in form of a voluntary national standard (GB/T). According to the work group on a global scale the draft standard is without precedent.
