REGULATORY REQUIREMENTSAccording to the definition in "Disinfection Management Measures", disinfectant products include disinfectants, disinfection equipment (including biological indicators, chemical indicators and packaging of sterilized items), sanitary products and disposable medical supplies. According to the requirements of “Hygiene Safety Assessment Provisions for Disinfection Products”, disinfectant products are classified and regulated by the risks degree based on their usage and use objects. Hygiene safety assessment for disinfectant products of Class I and Class II need to be done by notifier themselves or by a third party commissioned before placed on the market for the first time, and notifier shall be responsible for the evaluation results. Only disinfectant products with qualified hygiene safety assessment can be sold on the market.
National Health Commission of the People's Republic of China (NHC)
RELEVANT REGULATION AND MANAGEMENT MEASURES
- “Infectious Diseases Prevention and Control Act of the People's Republic of China”
- "Disinfection Management Measures"
- “Management Specifications for Labels of Disinfecting Products”
- “Hygiene Safety Assessment Regulations for Disinfecting Products”
- “Technical Specifications of Disinfect Products”
- “Measures for Health Administrative Permit”
- “Management Measures on the Administration of Hygiene Permit for New Disinfecting Products and New Water-Related Products”
DISINFECTION PRODUCT CATEGORY
According to the risks on usage and the use objects, the disinfection products are classified into three categories as following:
- Class I : disinfectant products with high risks. Strict management measures are needed to ensure the safety and effectiveness of products, high-level disinfectants and disinfection equipment for medical devices, sterilizing agents and sterilization equipment, skin mucosal disinfectants, biological indicators chemical indicator for sterilization and sterilization are included in this category.
- Class II: disinfectant products with moderate risks. Strengthened management measures are needed to ensure the safety and effectiveness of products. Disinfectants, disinfection equipment, chemical indicators other than the first category, and sterilization packaging with sterilization label and anti-bacterial preparations are included in this category.
- Class III: disinfectant products with low risk. The implementation of routine management can ensure the safety and effectiveness, including hygiene products other than antibacterial agents and bacteriostatic agent preparations.
Note: When the same disinfectant product is involved into different categories, it should be regulated by a higher risk category.
DISINFECTANT PRODUCT HYGIENE PERMIT AND RECORD REQUIREMENTS
Disinfectants manufactured or imported and disinfection equipment which utilized the new materials, new process technology and new sterilization principles should obtain the hygiene permit from National Health Commission of the People's Republic of China.
- Hygiene Permit
If a manufacture or Chinese responsible entity applies for hygiene permit for new disinfectant products, they shall submit the application to the NHC in accordance with the requirements of “Management Measures on the Administration of Hygiene Permit for New Disinfecting Products and New Water-Related Products”. NHC shall decide approve or not in accordance with relevant laws and regulations.
For manufacture or import of disinfectant, disinfection equipment and anti-allergic preparations other than new disinfectant products, the manufacture or importer shall carry out hygiene safety assessment, which should meet the requirements of hygiene standards and regulations. When the product is placed on market, the report shall be submitted to the provincial NHC administrative department and the record certificate shall be obtained.
- Record by The Provincial NHC Administrative Department
REQUIREMENTS ON HYGIENE PERMIT AND RECORD
To apply for hygiene permit for new disinfectant products, the following documents should be submitted:(1) Application form for new disinfectant products hygiene permit;
- Requirements on Hygiene Permit
(2) The manufacture capacity review opinions issued by the provincial health supervision agencies;
(3) Research and development report;
(4) Quality standards;
(5) Testing methods;
(6) Approved documents that the disinfectant products have been allowed to be manufactured and sold locally in the country where the product is manufactured (for importing new disinfection products);
(7) Authorization letter of the responsible entity in China (for importing new disinfection products);
(8) Power of attorney (required if entrusted agency for the registration);
(9) Other documents that may be helpful for the review.
A sample should be provided for the review. If products with length (width or height) ≥ 150cm and weight ≥ 100kg, only color photos (show the appearance and internal structures) should be provided.
Notifier applying for new disinfectant products shall log into the online application system of the Center of Inspection and Supervision of NHC for online notification first, and then submit application dossier and sample to the NHC.
- Requirement on Record for the First and Second Category Disinfectants
When Class I and Class II disinfectant products are placed on market for first time, the product responsible entity shall submit the hygiene safety evaluation report to the local provincial NHC administrative department for the record. The hygiene safety assessment generally includes basic information and evaluation information, the evaluation information includes:(1) Label, Instruction Manual;
(2) Test report (include conclusions);
(3) Enterprise standards or quality standards;
(4) Hygienic licenses for domestic product manufacturers;
(5) Approved documents that the disinfectant products can be manufactured and sold locally in the country (region) and customs declaration forms for the imported products;
(6) Product formula;
(7) Disinfecting device components and structure drawings.The product responsible entity shall be responsible for the authenticity of the sample. All test items should be completed using the same batch of product.
FLOWCHART ON HYGIENE PERMIT AND RECORD
OUR SERVICESCNCIC Product Registration and Compliance department has more than 20 years of experience in product registration and regulatory services, supporting worldwide clients with fast, professional and efficient regulatory compliance services:
- Regulatory advices;
- Product notification feasibility study;
- Tests placement and monitoring;
- Notification assessment, and professional advice;
- Assist the notifier prepare and submit the dossier;
- Assist the notifier prepare and submit the correction documents after the review;
- Follow up the review process, report timely, and support clients solve problems that may be encountered during the notification process;
- Training on disinfectant product regulations.