How to legally bring disinfection products onto Chinese market?

Original Article by David Wan, 28 Jan 2014

In July 2013, China repealed the registration requirements on existing disinfection products[reference]. Only "new" disinfection products are required to be registered with MOH. Although existing disinfection products do not require registrations or administrative approval, they need to undergo a safety evaluation process. A safety evaluation report should be prepared by Chinese responsible agents before the agents put disinfection products on Chinese market.

On 17 January 2014, the National Health and Family Planning Commission (NHFPC), previously called MOH, has issued a draft version of Regulations on Safety Evaluation of Disinfection Products for public consultations. The notice has set detailed requirements on the content and format of a safety evaluation report. For the English version of the template of safety evaluation report, please consult us.

According to the latest China Disinfection Regulations and the draft version of Regulations on Safety Evaluation of Disinfection Products, we have prepared a summary for overseas companies who intend to export disinfection products into China. You can take the following 6 steps to ensure compliance.

Step 1. Check if your products meet the definitions of disinfection products in China.

There are 5 categories of disinfection products in China, namely:

  • 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

Step 2. Determine whether your product is a new disinfection product or an existing disinfection product

The judgment criteria for a new disinfection product or an existing product can be accessed here. If your product is a new product, you shall register it and obtain a hygiene license from NHFPC. If your product is an existing disinfection product, you do not need to register it. However, you need to prepare a safety evaluation report. If you have questions, you may consult us any time.

Step 3. Conduct essential testing in qualified laboratories in China

Different test items are required for various types of disinfection products. The amount of test items mainly depends on the disinfecting object of disinfectants. All test items should be conducted in laboratories which have been certified by provincial authorities. Meanwhile, product samples should be sealed by provincial authorities before sample delivery and testing.

Step 4. Gather materials for the preparation of safety evaluation report

The following documents are required for the safety evaluation report for disinfection products imported into China.


Category 1, 3, 4 and 5

Category 2: Disinfection device

Certificate of sale in the country of origin

Customs declaration

Product label and specification

Testing report

Quality control standard

Recipe and raw material description


Main units description and structure diagram



1. Quality control standard should be notified to the Standardization Administration of China (SAC);

2. Product labels should meet the requirements of the administrative measures on disinfection product labels and specifications [2005].

3. Your products shall meet the requirements of relevant national hygiene standards in China;

Step 5. Product Notification

The responsible body of the imported products should notify provincial authorities within 10 days after imported disinfection products being made available on Chinese market.

Step 6. Get Some Help from CIRS Such As

  • Product Analysis & Cost Estimation
  • Disinfectant Registration Service
  • Chinese Responsible Agent
  • Safety Evaluation Report & Product Notification
  • In-house Training

About the Author

David Wan is the head of regulatory affairs team for pesticides and disinfectants in CIRS. David Wan graduated from Zhejiang University with Master Degree in life science. He has developed 4 years of consulting experience in chemical regulatory compliance, particularly in areas such as EU REACH, pesticide and biocide regulation compliance in China & Europe.


  • Mr David Wan, China Office
    11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
    Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533

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