Class I disinfection products: high-level disinfectants and disinfection instruments for medical devices, sterilants and sterilization devices, ** mucosal disinfectants, biological indicators, chemical indicators of sterilization effect;
Category II disinfection products: disinfectants, disinfection instruments, chemical indicators, as well as sterilization packaging and antibacterial preparations with sterilization marks in addition to the first category of products.
The responsible unit for disinfection products is required to conduct a health and safety assessment before the first and second class disinfection products are marketed for the first time. The production of the above three types of disinfection products needs to be filed with the elimination number.
Where is the elimination number recorded?I have developed a disinfection product, do I need to file it?
The elimination number needs to be filed with the Provincial Health DepartmentAfter the filing is successful, you can query on the webpage of the national disinfection product online filing information service platform, and the query is a legal elimination product.
Elimination of the number of the ICP filing process
1. Determine whether the product is an antibacterial product or a disinfection product.
2. Determine whether the ingredients of the product meet the national standard, and remember that Western medicine and hormone ingredients cannot be added.
3. According to the basic information of the product, draft the elimination number product information (as the basis for the elimination number detection).
4. Prepare samples for testing (the detection cycle of elimination number is generally 3-4 months).
5. Record the security assessment report.
6. Online filing.
The following information needs to be provided for the filing of the elimination number:
1. Label (nameplate), instruction manual;
2. The inspection report (including conclusions) issued by the laboratory certification and inspection agency - Zhongke Testing and Disinfection Product Testing Center;
3. Enterprise standards or quality standards that have been filed and within the validity period;
4. Product formula (or disinfection instrument components and structural drawings);
5. The health license of the production enterprise or the certificate and customs declaration form of the country (region) where the imported products are produced are allowed to be produced and sold.