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Nationwide registered "UV germicidal lamp" data is here

Source: 中国之光网 Views: 2147

"Regulations on Hygiene and Safety Evaluation of Disinfection Products" (Wei Jian Du Fa [2009] No. 105), to strengthen post-licensing supervision and management of disinfection products for which licensing has been cancelled, and to establish a hygiene and safety evaluation system.


The "Provisions on Hygiene and Safety Evaluation of Disinfection Products" (Guo Wei Jian Du Fa [2014] No. 36) and the "Work Specifications for Hygiene Supervision of Disinfection Products" (Guo Wei Jian Du Fa [2014] No. 40) implement risk-based regulation according to the intended use and target objects of disinfection products, classifying them into three regulatory categories. The entity responsible for the product must conduct a hygiene and safety evaluation independently or entrust a third party before the first IPO / Go public of Class I and Class II disinfection products, resulting in a "Hygiene and Safety Evaluation Report for Disinfection Products." Only disinfection products that pass the hygiene and safety evaluation may be marketed for sale.

"Technical Requirements for Hygienic Safety Evaluation of Disinfection Products" (WS 628-2018), as the first mandatory hygienic standard established for the hygienic safety evaluation of disinfection products, is used in conjunction with the "Provisions on Hygienic Safety Evaluation of Disinfection Products" (Guo Wei Jian Du Fa [2014] No. 36).

Disinfection products are classified into three categories based on their intended use and the risk level to the user:

1. Disinfection products with relatively high risk that require strict management to ensure safety and effectiveness, including high-level disinfectants and disinfection equipment for medical devices, sterilants and sterilization equipment, skin and mucous membrane disinfectants, biological indicators, and chemical indicators for sterilization efficacy.


2. Products with moderate risk that require enhanced management to ensure safety and effectiveness, including disinfectants, disinfection equipment, and chemical indicators other than Class I products, as well as packaging for sterile items with sterilization marks and antibacterial (bacteriostatic) preparations.


3. Products with a lower risk level, where routine management can ensure safety and effectiveness, excluding antibacterial (antimicrobial) preparations. (Note: No filing required)

When the same disinfection product involves different categories, it shall be managed according to the higher-risk category.

According to the "Notice on Further Precise and Standardized Implementation of Disinfection for COVID-19 Prevention and Control" (Joint Prevention and Control Mechanism Comprehensive Development [2022] No. 60) issued by the National Health Commission, the "Detailed Rules for Terminal Disinfection of Epidemic Foci," and the "Guidelines for Preventive Disinfection for the Public," consumers are clearly reminded to choose safe and effective disinfection products. Before purchase and use, compliance can be verified on the "National Online Registration Information Service Platform for Disinfection Products".

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Source: Light Research Market


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