On 28 January 2015, The National Health and Family Planning Commission of China (NHFPC) declared that disinfection product manufacturers should be inspected in 2015. This inspection program will be on the basis of relevant regulations, namely Prevention and Treatment of Infectious Diseases, Measures on the Administration of Sterilizing, and Prevention and Treatment of Occupational Diseases.
Inspection Program Highlights
1. Production inspection and supervision.
According to the requirements of Sanitary Guidance for the Manufacturer of the Disinfecting Products, local Authorities shall mainly inspect the sanitary condition, environment and layout of plants. Meanwhile, updating “Information Card of Disinfection Product Manufacturer” and completing the “Sanitary Supervision File for Manufacturer” are the other key inspection items.
2. Disinfection product detection.
Authorities shall concentrate on checking the registration or notification of the 1&2 Ties disinfection products, including product records, production process record, raw material transport record and batch testing record and so forth. Meanwhile, product claims and additives shall be reviewed to ensure their regulatory compliance.
3. Random testing for disinfection products.
Perform product quality inspection by verification testing for the 1&2 Ties disinfection products.
More detailed information about disinfection product notification please click here:
Here are the 3 Disinfection Product Ties for Authority Administration
Tie 1: High efficacy disinfectant and device, disinfectant for skin and mucous, Biological Indicator, Chemical Indicator for efficacy detection.
Tie 2: Disinfectant, device and chemical indicator not covered by Tie 1; Packaging materials for disinfected and sterilized product, Antibacterial and bacteriostatic agent.
Tie 3: Other disinfection products.
Here are the Disinfection Product Categories for testing identification
Category 1: Disinfectant
Category 2: Disinfection device
Category 3: Chemical and biological indicator
Category 4: Packaging materials for disinfected and sterilized product
Category 5: Antibacterial and bacteriostatic agent
1. Notice from NHFPC about special rectification program for disinfection product manufacturer and radiological health technique service organization.
2. The content of the administrative approval that the State decides to cancel or transfer to low level.
3. Notice from NHFPC about Regulations on the Sanitary Safety Assessment of Disinfecting Products.