Materials Needed For Registration Of NDP

Delivery term:The date of payment from buyers deliver within days
  • Price:

    Negotiable

  • minimum:

  • Total supply:

  • Delivery term:

    The date of payment from buyers deliver within days

  • seat:

    Shanghai

  • Validity to:

    Long-term effective

  • Last update:

    2017-06-30 14:59

  • Browse the number:

    263

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Company Profile
Randis Chemwise (Shanghai) Co.,Ltd
Contactaixin:

hsou041(Mr.)  

Email:

telephone:

phone:

Arrea:

Shanghai

Address:

Room 2404, Tongda Chuangye Bld., No. 1, Lane 600, Tianshan Road, Changning District, Shanghai 200051, P.R.China

Website:

http://www.randiscn.com/ http://www.that-it-company.com/com/hsou041/

Product details

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

±

Overall performance test

+: mandatory
-: not needed
±: maybe needed
①~⑦: detail requirement exists.

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