Classified supervision and administration
Disinfectant products are classified and managed according to the use of disinfectant product, degree of risk of the target object.
ClassⅠdisinfectant product
Disinfectant products with high risk need strict administration to ensure the safety and efficiency.
Include: High-level disinfectants and disinfection apparatuses, sterilizers and sterilization instruments, skin / mucosal disinfectants used in medical devices, biological indicator, chemical indicator of sterilization effect.
Class Ⅱ disinfectant product
Disinfectant products with medium risk need strengthening administration to ensure the safety and efficiency.
Include: Disinfectants, disinfection instruments, chemical indicators, packages of sterilized articles with sterilization logos and antibacterial(bacteriostat) agents other than classⅠproduct.
Class Ⅲ disinfectant product
Sanitary products with low risk other than antibacterial (bacteriostat) agents need regular administration to ensure the safety and efficiency.
The administration should be implemented in high risk class when the same disinfectant product involves different classes.
Enterprises Obligations and Countermeasures
Responsible entity
Individuals, legal persons and other organizations that are legally liable for compensation for personal injury or property loss caused by product defects.
When entrusting production and processing, it refers to the entrusting party. And the responsible unit for imported products is the Responsible Entity in China.
Responsible entity for products shall evaluate the health safety on its own or by entrusting a third party before ClassⅠdisinfectant product and Class Ⅱ disinfectant product are listed for the first time. Disinfection products that pass the health and safety evaluation can be sold on the market.
Before ClassⅠdisinfectant product and Class Ⅱ disinfectant product are listed for the first time, responsible entity for products should submit their health safety evaluation report for notification to local health regulatory department.
Hygiene and safety evaluation of disinfectant product
Health safety evaluation of disinfection products is the comprehensive evaluation on efficiency and health safety of disinfection products, and the evaluation content includes:
- Product label (nameplate) and instruction
- Inspection report (including conclusion)
- Enterprise standard or quality specification
- Hygiene License for the Production Enterprise of Domestic Products or, Certification document of allowing production and sale by origin country(region) of imported products and Customs declaration
- Product formula
- Structure diagram of disinfection apparatus(Main components and parameters)
The period of validity of the health safety evaluation report of ClassⅠdisinfectant product is 4 years, and the health safety evaluation report of Class Ⅱ disinfectant product is long-term valid.
Regulations(to name just a few)
- Infectious Diseases Control Law
- Food Safety Law of the People’s Republic of China
- Disinfection Management Measures
- Technical Standard For disinfection (2002 Edition)
- Hygienic Practices for Production Enterprises of Disinfection Products
- Provisions for the Hygiene and Safety Evaluation of Disinfectant Products
- Work Specification for Hygiene Supervision of Disinfection Products
- Judgement Basis of New Materials, New Process Techniques and New Sterilization Principle
National and industrial standards(to name just a few)
- WS 628-2018 Technical Requirements for the Hygiene and Safety Evaluation of Disinfectant Products
- GB 38598-2020 General Requirement for Label and Instruction Book of Disinfection Products
- GB 38850-2020 List for Materials and Restricted Substances in Disinfectant
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