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China Disinfectant Notification

China,Notification,Disinfection,Products,Type

Disinfection products refer specifically to a kind of health products which can be used to kill or eliminate pathogenic microorganisms in the vectors and can prevent or control infectious disease by chemical, physical or biological methods.

Type of Disinfection Products

Disinfection products can be classified in different ways. The most common classification is divided into 3 types in terms of risk level of application objects as below:

  • Class I is disinfection products which are of high risk and need to be supervised strictly 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 skin or mucosa, biological indicators and chemical indicators with disinfection and sterilization efficacy
  • Class II is disinfection products which are of medium-risk and need to be strongly supervised to ensure their safety and effectiveness. These include disinfectants and disinfection devices other than those in class I, antibacterial and bacteriostatic agents, chemical indicators, packages of sterilization articles with corresponding logo etc;
  • Class III is sanitary products other than antibacterial (bacteriostatic) agents. This kind of disinfection products are of low risk and can be routinely supervised to ensure their safety and effectiveness. These include sanitary absorbent pads, pantiliner, and tampon, excreta hygiene products like diapers, hygiene products for skin and mocosa like wet wipes and hygiene wet wipes, and other hygiene products like paper towels, makeup cotton, etc. 

Under the Measures for the Administration of Disinfection revised in 2017, when disinfection products other than new disinfection products are manufactured in or imported to China, the manufacturers and import enterprises need to make the hygiene and safety evaluation on disinfectants, disinfection devices and antibacterial (bacteriostatic) agents of sanitary products to submit to provincial Health Commission for filing. Foreign companies shall appoint a Chinese responsible agent to deal with notification and oversee the safety of products marked in China.

Application Types

Disinfection products of class III can be exempt to official notification. The class I and class II must be notified before production, importation and sale.

Filing of Class Ⅰ

Electronic filing certificate is valid for 4 years

Filing of Class Ⅱ

Electronic filing certificate is always valid as long as the product information does not change

Our Services

Disinfection Product Notification

  • Determining the type of disinfection products so as to confirm the type of notification.

  • Regulatory compliance testing in product safety and efficacy

  • Full dossiers preparation and submission