REACH24H Consulting Group

Value in Compliance

6 Musts when reviewing the Health Safety Evaluation Report of a Disinfection Product in China Featured

Abstract: The health safety evaluation report is the most important review basis for disinfection products in China. Therefore, foreign enterprises should pay more attention to some key points in order to avoid administrative penalties from the Public Health Authority.

When it comes to the final review of Health Safety Evaluation Reports for Disinfection products, there are a number of key points that are often overlooked, and which may determine a Report’s rejection, or even subject it to penalties from the relevant Health authority. Below, AMD Technical Team has summed up some key issues to take into account:

1)       The Subject indicated in the Health Safety Evaluation Report must be the Chinese production company or responsible legal entity in China for the imported product.

2)       The content of the Health Safety Evaluation Report should include all of the following: label, specifications, test report, enterprise standard or product quality standard, hygiene license of the domestic product manufacturer, certificate of production and sale in country of origin for imported product, product formula for disinfectant, main components and structure chart for disinfecting apparatus.

3)       The Health Safety Evaluation Report should be valid in the whole Chinese territory. The period of validity of Class I disinfectant products is four years, while Class II disinfectant products have a longer validity period.

4)       The Health Safety Evaluation Report should be re-registered prior to the expiry date for Class I disinfectant products. When testing disinfection products, only key projects will be done. For example, active ingredient content, pH value and one of the most resistant microbial killing tests for disinfectant, main bactericidal factor strength and one of the most resistant microbial killing test for disinfecting apparatus.

5)       Tests will have to be retaken in the following cases:

 

Test items

Disinfectant

Disinfecting apparatus

Factory is relocated

Active ingredient content, stability test, pH

Main bactericidal factor strength

Branch factory or workshop is set-up

Expiration date is extended

Active ingredient content, pH, one of the most resistant microbial killing tests and stability tests; if use original test sample, only stability test is required.

/

Scope of use or change the method of use is increased

Physical and chemical testing, microbial killing test, toxicological test


6)       Lastly, the testing of disinfection products should be carried out in labs that hold the corresponding CMA (China Metrology Accreditation) qualification. The report will require the CMA mark.

You are here: News Disinfectant 6 Musts when reviewing the Health Safety Evaluation Report of a Disinfection Product in China