Regulation of Disinfectants
In China, disinfectants are regulated by the following provisions under the responsibility of the Ministry of Health (MOH):
- Measures for Management of Hygiene Administrative License (1987, updated 2002)
- Measures on Disinfectant Administration (2004)
- Provisions on application of new disinfection product (2014)
- Judgment for disinfectant and disinfection device manufactured in new material, new technology and new disinfection mechanism (2013)
- Hygiene safety evaluation report of disinfection product (2014)
According to the above regulations, companies planning to import disinfectants into China must apply for and obtain a hygiene license for the product. For imported disinfectants, an application must be submitted to the National Centre for Health Inspection and Supervision (NCHIS) of the Ministry of Health.
Local Agent – Only Representative in China
The notification of disinfectant products (and others) by foreign companies without a subsidiary in China requires the appointment of a so called "Local Agent" for the respective Chinese market area (e.g. China mainland).
The function of the Local Agent is quite similar to the role of an Only Representative under EU REACH or a trustee. However, submission of the notification dossier to the Chinese authority is only feasible when the Local Agent has a Chinese "Sales License" for concerned products at hand.
Disinfectants – Intended Uses
Products 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
In cooperation with our partner in China, China National Chemical Information Center Co. Ltd (CNCIC), we take care of your regulatory needs for obtaining the hygiene license for your product. Our services include:
- Developing individual regulatory strategy, including testing strategies
- Study planning and monitoring
- Preparing and submitting applications, incl. follow up and defense
- Support with “typical” Chinese documentation requirements, such as the “Sales License”
- Communicating with responsible authorities
- Local support via our partner
- Translations into Chinese
Contact our specialists to learn how we can assist you in effectively managing your regulatory obligations in the Chinese disinfectants market.