Terms that get used loosely
China's disinfection product rules are commonly described in English as a “registration” system. The word causes practical problems. For most existing products, the obligation is a filing (备案), submitted to the provincial department of disease control and prevention. The substantive responsibility for the safety and efficacy evaluation sits with the company that puts the product on the market. EPA registration and EU Biocidal Products Regulation authorisation are different processes, with different review depth and different legal consequences.
Two other terms need separating. Products made with new materials, new production processes or new disinfection principles are classified as new disinfection products (新消毒产品). They are not filed; they require administrative approval at national level. Separately, an overseas manufacturer does not need a Chinese production hygiene licence in order to file.
| What it is | Chinese | What to call it | Who decides | What you get |
|---|---|---|---|---|
| Existing disinfectants, disinfection devices and antibacterial (bacteriostatic) preparations | 消毒产品备案 | filing | Provincial department of disease control and prevention | A public record on the national platform, not a certificate |
| Products using new materials, new processes or new disinfection principles | 新消毒产品卫生行政许可 | administrative approval | National Disease Control and Prevention Administration (NCDPA) | An administrative approval (hygiene licence) |
| Production carried out inside China | 消毒产品生产企业卫生许可 | production licence | Province | Required for domestic manufacturers of disinfectants and devices; not required for overseas manufacturers |
| (for comparison) | — | EPA FIFRA registration / EU BPR authorisation | — | — |
Step 1: Is the product inside the regime? (What counts as a disinfection product)
Scope is decided by two things: what the label claims, and where the product is used. A product whose label claims only cleaning, deodorising or moisturising action is not a disinfection product under Chinese rules, however active its formulation may be.
The claim side is regulated in its own right, and the words on the label largely decide which door the product goes through. Four claim families bring a product into this regime.
| Claim on the label | Meaning | Where it leads |
|---|---|---|
| 灭菌 | Sterilisation: killing all microorganisms, including spores | Disinfection product, in the highest-risk group |
| 消毒 | Disinfection: killing or removing pathogenic microorganisms | Disinfection product; class depends on the target |
| 抗菌 | Antibacterial: killing bacteria | Antibacterial (bacteriostatic) preparation, limited to intact skin (hands) and mucous membranes |
| 抑菌 | Bacteriostatic: inhibiting bacterial growth | Same as above |
The target side is defined by two documents. The statutory scope list dates from 2002 and was adjusted in 2005. The mandatory evaluation standard WS 628-2018 sets out the disinfection targets against which disinfectants and disinfection devices are actually tested. Between them, the following targets fall inside the regime.
Class I products
| Target | Note |
|---|---|
| Medical devices and instruments | Sterilisation, high-level disinfection, endoscopes |
| Skin | |
| Mucous membranes | For use by medical institutions only |
Class II products
| Target | Note |
|---|---|
| Medical devices and instruments | Intermediate-level and low-level disinfection |
| Surgical hand | |
| Hygienic hand | |
| Drinking water | |
| Swimming pool water | |
| Hospital sewage | |
| Hard surfaces | |
| Textiles and other porous surfaces | |
| Tableware and drinking utensils | |
| Fruit and vegetables | |
| Food-processing tools and equipment | |
| Indoor air | |
| Waste | Excreta, secretions, blood, and contaminated items and environments |
Several categories fall outside. Products for livestock farms, farmed animals or household pets are outside. So is anything aimed at food other than fruit and vegetables. In 2005 the authorities removed products for specific body parts (feet, eyes, nails, armpits, scalp, hair and nasal mucosa), together with masks and condoms.
Being outside this regime does not mean being unregulated. It means that this set of rules does not apply, and whether another does depends on the product and the claim. That has to be settled case by case.
Step 2: New or existing
“New” has three limbs, and a product counts as new if it meets any one of them.
New material: an active ingredient that is not on the list of permitted disinfectant raw materials, is not in the Pharmacopoeia's disinfectant and preservative category, and is not covered by a current national hygiene standard.
New production process: a change in technical parameters or process flow that makes the product equal or superior to conventional products in effectiveness, safety and environmental adaptability.
New disinfection principle: a mechanism of action, or an indicator for it, that is not on the existing lists of disinfection factors and the corresponding devices and indicators.
New products cannot be filed. They go to the national authority for administrative approval. As of September 2026, one new disinfection product has been approved since the regime was introduced in 2014. Where a reformulation onto the existing raw-material list is possible, that option is usually the shorter route to compliance.
Step 3: What has to be filed, and under which class
The most recent statutory statement is Article 38 of the Law on the Prevention and Control of Infectious Diseases, revised on 30 April 2025 and in force since 1 September 2025. It requires that disinfectants, disinfection devices and antibacterial (bacteriostatic) preparations — other than new products — be filed with the provincial department of disease control and prevention. New products are approved at State Council level.
| Class | Risk | Typical members | Filing required? | Evaluation report |
|---|---|---|---|---|
| I | Higher | High-level disinfectants and sterilisers for medical devices; sterilants and sterilising devices; skin and mucous membrane disinfectants; biological indicators; sterilisation chemical indicators | Yes | Valid four years, then re-evaluation |
| II | Moderate | Disinfectants, disinfection devices and chemical indicators outside Class I; sterilisation-marked packaging for sterilised items; antibacterial (bacteriostatic) preparations | Yes | Indefinite, but must be updated whenever the product changes |
| III | Lower | Sanitary products other than antibacterial (bacteriostatic) preparations | No | — |
Wipes sit in the third group. Ordinary wipes, hygienic wipes and disinfecting wipes are all outside the filing obligation, and this applies to the whole wipe family. They remain covered by product standards: GB/T 27728.1-2024 for general wipes, in force since 1 October 2025; GB/T 27728.3-2024 for disinfecting wipes; WS 575-2017 for hygienic wipes; and GB 15979-2024, in force since 1 July 2025, underneath all of them.
Step 4: What the process involves
If the product is in scope, the process runs roughly as follows. You designate a responsible entity in China; one product can be tied to only one. That entity submits a hygiene and safety evaluation report with supporting documents. Testing must be carried out by a qualified laboratory inside China. The dossier is built to WS 628-2018, a mandatory Chinese health-industry standard. Proof that the product may be produced and sold in its country of origin is also required.
Two features of this process are commonly described differently in English-language guides.
Submitting the dossier is not the end of the process. The provincial authority reviews it and issues comments. You respond, correct and supplement, and this can run to more than one round.
There is also no filing certificate in practice. What a successful filing produces is a public record on the national filing platform, searchable by product name or by responsible entity. That record is what customers, hospitals and e-commerce platforms will use to verify the product.
Two common misconceptions
Soap and liquid are treated differently. The classification catalogue covers antibacterial (bacteriostatic) washing agents “excluding suppositories and soaps”. A liquid antibacterial hand wash therefore falls inside the filing regime. An antibacterial soap bar does not, and is not a disinfection product at all. The same claim leads to two different routes, and the dividing line is the physical form.
A filing is not a one-off. If the formulation, structure or production process changes, if the shelf life is extended, or if a use site is added or the method of use changes, the product must be re-tested, the evaluation report updated, and a fresh filing made with the original authority.
What it costs to skip the filing
Article 108(4) of the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases, as revised in 2025, addresses products that should have been filed but were not. Producing or selling them leads to an order to correct, a warning or public criticism, confiscation of illegal gains, and a fine of up to RMB 100,000. In serious cases the relevant licence can be revoked. Under Article 107(4), producing or selling new disinfection products made using new materials, new process technologies or new disinfection principles without the required hygiene licence can lead to confiscation of illegal gains and a fine of up to RMB 200,000. In serious cases, the relevant licence may be revoked and directly responsible personnel may be prohibited from engaging in the corresponding production or business activities for five years.
How REACH24H Can Help
REACH24H supports companies with China disinfection product classification, regulatory pathway assessment, hygiene and safety evaluation, testing coordination, filing, new disinfection product applications and label review.
View China Disinfectant Compliance Services Contact UsOfficial Sources
Law of the People's Republic of China on the Prevention and Control of Infectious Diseases — Articles 38, 107 and 108.
Provisions on Hygiene and Safety Evaluation of Disinfection Products — National Health Commission.
National Online Filing Information Service Platform for Disinfection Products — National Health Commission.
