China Disinfection Products Filing
Since the official implementation of the “Decision of the State Council on Cancellation and Transfer of 50 Items of Administrative Permits and Other Affairs” on July 22, 2013, non-new materials, new technologies, and new principles disinfection products imported and sold legally in Chinese Mainland must have completed filing with the Provincial Health Commission.
China implements registration management for new materials, new technologies, and new principles disinfection products and filing management for general disinfection products. Any enterprise or individual who sells disinfection products without registration or filing will face severe punishment once identified.Feel free to hit me up by booking a meeting.
What is the Definition of Disinfection Products？
Products specifically designed to kill and eliminate pathogenic microorganisms on transmission media, preventing and controlling infectious or communicable diseases.
General disinfection products
What are imported disinfection products?
Imported disinfection products refer to those manufactured outside of China.
Disinfection Products Classification
Note: If the same disinfection product involves different classes, it should be managed in the higher risk class.
China Disinfection Products Filing Process
Period: General disinfection products notification (within 4-9 months, excluding tests)
China Disinfection Products Filing Requirements
1. Disinfection Products filling information form and related documents
2. Product name information
3. Product formula
4. Product quality standard
5. Product label and Instruction book template
6. Product testing report
Our Services Related to Disinfection Products Filing
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Before the project start-up
1. Free product classification, primary screening of new ingredients, prohibited substances in China check, etc. ​
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2. The formulation of application solutions or project feasibility analysis.
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Project start-up
1. Account application: guide the company to fill in relevant information, complete the authorization of the responsible person, and sort out or establish a product quality standard with our assistance.​
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2. Product review: review whether the ingredient, formula, label, efficacy claims, etc. of the product comply with relevant regulations, and define the feasibility of registration or filing.
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Mid-term of project
1. Product inspection: carry out necessary tests in China, such as microbiological tests, physicochemical tests and toxicology tests.
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2. Documents preparation and review: guide the company to sort out or draft other documents, such as production quality standards, free sale certificates, entrusted processing agreements, and review if all the files meet the requirements.
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3. The Hygiene and Safety Assessment writing and product dossier compilation.
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Later stage of project
1. Filing documents review: build a good relationship with relevant government departments, directly discuss and solve key problems with the Provincial Health Commission experts.
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2. Dossier submission: a special person is responsible for sorting out the paper data and completing the submission.
