According to “Law of the People's Republic of China on the Prevention and Treatment of Communicable Diseases”, “the Measures for the Administration of Disinfection”, “the Measures for Health Administrative Licensing” and other relevant regulations, enterprises engaged in the production and sale of class I and class II disinfection products should submit disinfectant filing applications for their products before related selling activities. Foreign companies shall appoint a Chinese responsible agent to deal with notification and oversee the safety of products sold in China market.
▌Definition of disinfectant
According to the provisions mentioned in Article 45 of “the Measures for the Administration of Disinfection” (Order No. 27 of the Ministry of Health, implemented since July 1, 2002), disinfection products include disinfectants, disinfection instruments (including biological indicators, chemical indicators and packaging materials for sterilized articles), sanitary supplies and disposable medical supplies.
According to Article 78 of “Law of the People's Republic of China on the Prevention and Treatment of Communicable Diseases”, disinfection refers to the chemical, physical and biological methods used to kill or eliminate pathogenic microorganisms in the environment. Therefore, disinfection products can be understood from the perspective of the difference between disinfection products and drugs as follows :
(1) In terms of function and purpose,disinfection products are not produced to cure or diagnose diseases;
(2) In terms of mechanism of action, disinfection products are products using chemical, physical and biological methods to eliminate pathogenic microorganisms, rather than products that can prevent diseases via pharmacological or immunological methods;
(3) In terms of target, disinfection products aimed at pathogenic microorganisms in the environment rather than human diseases.
▌Classification and management of disinfection products
Disinfection products can be divided into 3 types according to different product usages and risk levels as below:
◆ Class I products are disinfection products with high level of risk that require strict management to ensure their safety and effectiveness. These include high-level disinfectants and disinfection devices used on medical devices, sterilizing agents and sterilization devices, disinfectants for skins or mucosae, biological indicators and chemical indicators with disinfection and sterilization efficacy;
◆ Class II products are disinfection products with medium level of risk that require reinforced management to ensure their safety and effectiveness. These include disinfectants, disinfection devices, chemical indicators other than class I products, packages of sterilization articles with corresponding logo, antibacterial and bacteriostatic agents;
◆ Class III products refer to sanitary products other than antibacterial (bacteriostatic) agents. This kind of disinfection products are of low risk and only require general management to ensure their safety and effectiveness. These include sanitary absorbent pads, pantiliners, and tampons, excreta hygiene products like diapers, hygiene products for skins and mucosae like wet wipes and hygiene wet wipes, and other hygiene products like paper towels, makeup cotton, etc.
For a disinfectant product in either Class I or Class II, the responsible parties must submit their disinfectant recordation application before marketing for the first time. A disinfectant product can only be marketed after being qualified by corresponding hygienic safety evaluation.
◆ product label(Nameplate)
◆ product manual
◆ test report （with conclusions）
◆ certification documents for production and sales of imported products in the country (region) of origin
◆ customs declaration form
◆ Structure diagram of disinfection instrument (main components and parameters)
◆ Act as your reliable agent
◆ Hygienic safety evaluation
◆ Test lab selecting and study monitoring
◆ Policy and regulation consultation
◆ Compliance analysis report
◆ New disinfection products declaration
◆ Test supervision and test report review
◆ Label management
◆ Online/On-site regulation training
◆ Legal document translation
◆ Discussion, liaison and negotiation with authorities