Disinfectant Registration in China
Original Article by David Wan in 2012
In China, disinfectants are regulated by the following regulations:
- Measures on Disinfectant Administration issued by the Ministry of Health (MOH) in 2002;
- Guidance on Application of Administrative Approval License of Disinfectants and Disinfecting Apparatuses (2006);
- Administrative licensing procedure for health-related products(2006);
According to the above regulations, any companies who plan to place a disinfectant on the Chinese market must apply for and obtain a hygiene license for the product first. Foreign companies are required to appoint a Chinese responsible agent to deal with this application. For imported disinfectant, an application must be submitted to the National Centre for Health Inspection and Supervision (NCHIS) of the Ministry of Health. For domestic disinfectant, an application shall be submitted to health authorities at provincial level.
What is New?
China has repealed the registration requirements of existing disinfectant and disinfection devices in 1013. Only "new" disinfection products require registration with MOH. For the latest info on how to legally bring disinfection products to China, please click here.
The Scope and Definition of a Disinfectant in China
In China, disinfectants are considered as health-related products. The health-related products mainly include disinfectants, disinfecting equipments and drinking water-related products.
Any chemical with the following intended uses are regarded as disinfectants in China:- To disinfect/sterilize medical and health consumable goods;
- To disinfect skin/mucosa;
- To disinfect tableware;
- To disinfect fruit and vegetable;
- To disinfect water;
- To disinfect environment;
- To disinfect the surface of an object;
- To disinfect air;
- To disinfect the sewages including excrements, secretions
A typical disinfectant in China is hand sanitizer. Please note that some chemicals which meet the above definitions do not require hygiene licenses, for example, 75% ethanol.
Documents Required for Registration
The following documents are required for the registration of a disinfectant with health authorities in China.
- Application form;
- Research and development report (*);
- Product formula (*);
- Description of manufacturing process and flow chart(*);
- Quality and safety control standard (*);
- Test reports issued by laboratories designated by the Ministry of Health;
- Original packaging (*);
- Product manual (*);
- Certificate of free sale at the country of origin(*);
- Power of attorney in case of using a local agent;
- Any other documents that maybe helpful for the review (*)
- One sealed sample in a small package (*).
Please note:
(1) Those items marked in * should be provided by clients. CIRS will translate them into Chinese and prepare all documents in standard format to meet authority’s requirements;
(2)Disinfecants for drinking water-related products are subject to different registration requirements.
Procedure & Timeline
It takes at least 10 months to register a regular disinfectant in China. The table below summarizes the procedure and the timeline of the registration of a regular disinfectant.
Step |
Time |
Notes |
|
1 |
Product analysis |
5 Working days |
CIRS determines whether a product meets the definition of a disinfectant in China, analyzes which test items are required and estimates the total costs of registration. |
2 |
Testing(*) |
3 Months |
Test should be conducted in official labs designated by MOH; |
3 |
Dossier preparation |
20 Working days |
CIRS will translate all documents and put all required documents into one dossier. |
4 |
Dossier submission |
5 Working days |
CIRS will submit the dossier to health authorities. |
5 |
Format review |
5 Working days |
Health authorities will conduct completeness check to see if any document is missing or not compliant. |
6 |
Technical review |
70 Working days |
Health authorities will organize an expert committee to conduct technical review of the dossier submitted. |
7 |
Issue of hygiene license |
20 Working days |
|
Total |
10-14 months |
|
|
(*)Test items vary significantly from one product to another product depending on the use of a disinfectant. In general test items include efficacy studies, acute toxicity studies, skin/eye irritation test and skin sensitization test. Some chronic toxicity studies and chronic studies may be required depending on the results of acute toxicity studies.
Registration Cost Estimation
Generally, the total cost of registration of a regular disinfectant is between 48,000 and 88,000 RMB. The cost consists of three parts: testing fee, administrative fee and consultancy service fee.
The testing fee depends on product type and the use object of a disinfectant. In general, the testing fee is between 25,000 - 45,000 RMB for a regular disinfectant. The administrative fee is 3,000 RMB per product and is charged by authorities.The consultancy service fee is between 30,000 - 60,000 RMB depending on product type.
CIRS Disinfectant Registration Service
- Product Analysis & Cost Estimation
- Disinfectant Registration Service
- In-house Training
- Consulting Service
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.
Contact
- 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
Email: david@cirs-reach.com
