Disinfection product testing and filing
Disinfection product testing and filing
Product testing
The first category of disinfection products with higher risk includes high-level disinfectants and disinfection equipment for medical apparatus, sterilizers and sterilization equipment, skin mucosal disinfectants, biological indicators, and chemical indicators of sterilization effect. The second category of disinfection products with moderate risk includes other disinfectants, disinfection equipment, chemical indicators, as well as sterilized goods packaging with sterilization labels, and antibacterial (antibacterial) preparations. Health and safety testing and evaluation are required before listing.
filing declaration
When the first and second types of disinfection products are listed for the first time, the product responsible unit shall file the health and safety evaluation report with the provincial health and family planning administrative department where it is located. The provincial health and family planning administrative department conducts a formal review of the health and safety evaluation report. Fuda provides customers with professional filing and declaration services, strong technical support and cycle advantages, and provides efficient guarantee for the listing of customers' products.
component analysis
The content and stability of active ingredients need to be monitored when disinfection products leave the factory for testing to ensure the effect of disinfection products. Fuda has been focusing on the research of disinfection product quality control for many years, and the laboratory has developed its own testing methods, which can quickly and accurately determine the content of active ingredients.
Regulatory consultation
According to the requirements of relevant laws and regulations, the use of new materials, new process technologies and new sterilization principles to produce disinfectants and disinfectants, as well as the import of new disinfection products, are required to submit application materials to the competent department of the National Health and Family Planning Commission for filing, pass the product safety and efficacy review, and obtain the license approval/publicity before production and sales.
Toxicological evaluation
Disinfectant chemical chemical products will be mixed with some toxic by-products due to chemical reactions, production processes and other reasons during the production of raw materials and finished products, causing harm to the human body. Relevant state departments require such products to be assessed for toxicological indicators before they are put on the market, and products that have passed the toxicological inspection can be put on the market for sale.
