Materials Needed For Registration Of NDP
Materials Needed for Registration of New Disinfection Products
Key materials:
1. Production capacity audit result by China provincial Health Inspection Bureau (applicable for China domestic disinfection products)
2. Research and manufacture report
For new disinfectant:
· Report on research development in China and international.
· The R&D process and the technical supports for the R&D.
· Formula of the product with CAS numbers.
· Sterilization mechanism of active ingredients.
· Manufacture technical process
· Concentration of main active ingredients, and research progress report for the concentration selection.
· Research report on bactericidal effect and synergistic bactericidal effect if multiple active ingredients exist in the product.
· Research report on microbial killing effects.
· Research data on impact factors of sterilization, disinfection effect, e.g. temperature, relative humidity, impact by organic substances, and these shall be described in User Brochure.
· Research data on corrosivity to metals.
· Research data on relevant toxicological safety.
· Research data on degradation of product in the environment.
· Research data on the product's stability and term of validity for continuous use.
For new disinfector: (omit).
3. Quality standard
4. Test method
5. Certificate (proof) issued by the country (area) of the manufacture for allowing production and sales in the country (area) (applicable for imported disinfection products).
6. China local representative nomination letter (applicable for imported disinfection products).
7. Other materials helpful for the evaluation.
Example of test items (similar requirement exists for disinfectors):
Test Items for Disinfectants (for both New and non-New disinfectants)
Test Items | Disinfection Objects | |||||||||||||
skin | mucous membrane | hand | tabl eware | Fruit/ vegetable | Drinking water | Swimming pool water | Hospital sewage | air | medical appliance | General surfaces and fabrics | Others | |||
Sterilization and high level disinfection | Middle level | Low level | ||||||||||||
Appearance | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
Active ingredient concentration | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
pH① | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
Stability | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
Stability for continuous use | － | － | － | ± | ± | － | － | － | － | ± | － | － | － | ± |
Pb, Sb, Hg② | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | － | － | － | － | － | － | － | ± |
Metal corrosivity | － | － | － | ± | ± | － | － | － | ± | ＋ | ＋ | ＋ | ± | ± |
Laboratory measurement of microbial killing effect ③④⑤ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
Simulated field test or field test⑥ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ |
Toxicology ⑦ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | ＋ | － | ± | ＋ | ＋ | ＋ | ＋ | ＋ |
Overall performance test | － | － | － | － | － | ＋ | － | － | － | － | － | － | － | － |
＋: mandatory
－: not needed
±: maybe needed
①~⑦: detail requirement exists.
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