REGULATORY INSIGHT
China's National Disease Control and Prevention Administration (NCDPA) publishes a selection of the enquiries it receives, together with its answers. Between November 2023 and August 2026 it published 71 of them. Forty-two have something to do with disinfection products.
We have grouped those answers by the question being asked. They are useful for a practical reason: they show how the regulator actually applies the rules, including in the places where the written rules say nothing. Two things to keep in mind as you read. Each answer was written for one particular question, so none of them is a rule of general application. And when a question depends on the facts of a single product or a single filing, the NCDPA's usual response is to send the enquirer to the province.
Where the exact wording of an answer matters, we quote it and mark it as the reply's own wording. Everything else is our summary, arranged by question.
1. If it isn't in the catalogue, it isn't a disinfection product
Questions about scope come up more than any other kind. If a product is not listed in the Catalogue of Disinfection Products (消毒产品分类目录), the answer is that it is not a disinfection product. The NCDPA usually adds a consequence that many enquirers seem not to have considered: under the labelling rules, a product outside the catalogue may not carry any hygiene licence number connected with disinfection product regulation.
On that basis the NCDPA has put outside the scope anti-fog wipes for lenses; baby wipes; kitchen paper and kitchen cloths; facial cleansing towels and cotton-soft towels, compressed ones included; disposable bedding; disposable socks; wet toilet paper and toilet wipes; wipes for non-human use, such as shoe, kitchen, pet and car wipes; and mite and lice products. Breast pads and disposable underwear got the same answer.
One reply shows how far this reasoning can travel. A company had designed a device that generates chlorine dioxide to break down formaldehyde in the home, and asked whether GB 28931—2024 applied to it. The NCDPA said only that the product is not a disinfectant. Set that beside the catalogue replies, and the deciding factor looks like the claimed use rather than the active ingredient.
2. What GB 15979—2024 does not cover
Another cluster of questions concerns the reach of GB 15979—2024, the hygiene standard for disposable sanitary products. The answers here are consistent: if the standard does not list a product, the standard does not apply to it. The NCDPA has said so for facial and cleansing towels, including compressed and cotton-soft types; for disposable bedding; for disposable socks; for wet toilet paper and toilet wipes; and for object wipes such as stain removers and shoe wipes.
One answer goes a step further, and it is the most useful part of the set. A product that is in neither the catalogue nor the scope of GB 15979—2024 does not have to be labelled with GB 15979—2024.
3. What filing is, and is not
In its reply of 17 December 2024, the NCDPA explains what online filing means for the company responsible for the product.
Online filing puts the hygiene and safety evaluation report on record for later inspection. Filing does not constitute administrative approval.
Original wording (excerpt): “消毒产品卫生安全评价报告网上备案为告知、备而待查性质，不属于行政审批。”
The NCDPA cites Article 2 of the 2015 notice on oversight of disinfection products during and after market entry (国卫监督发〔2015〕90号). The entity responsible for the product has primary responsibility for ensuring that the report is true, valid and complete.
4. Production licences: who needs one
Two replies deal with the overlap between licensing regimes.
A manufacturer of medical gloves or finger cots that already holds a medical device registration number does not need a disinfection product production hygiene licence.
A manufacturer of paper tableware that already holds a national industrial product production licence does not need a disinfection product production licence.
The glove reply also settles a definition. The gloves and finger cots in the catalogue are the ones used in diagnosis and treatment in medical institutions. PE gloves for handling food are not among them.
One point the NCDPA was not asked about, but which matters to overseas manufacturers: a foreign manufacturer does not need a Chinese production licence in order to file. For an imported product the dossier rests on the document permitting production and sale in the country of origin, plus the customs declaration.
5. Old documents that are still in force
People keep asking whether documents older than the current standards still hold. The answers on this are short and consistent:
The rules on labelling and instructions for disinfection products (卫监督发〔2005〕426号) remain in force alongside GB 38598—2020, the standard for disinfection product labels and instructions.
The 2003 rules on testing disinfection products (卫法监发〔2003〕44号) remain in force.
The notice on the campaign against unlawful efficacy claims and added drugs (卫办监督发〔2009〕42号) remains in force.
6. On specific filings, there is no national answer
If a question turns on the facts of a particular product or a particular filing, the NCDPA will not answer it. The standard response is that, under the division of responsibilities, the provincial disease control department handles filing and the management of disinfection products, and the enquirer should consult that department.
Two examples. Whether a disinfectant already filed at one net content needs separate filings for other net contents. Whether the instructions drafted for an antibacterial spray were acceptable. Both went to the province.
This follows from Article 38 of the Law on the Prevention and Control of Infectious Diseases, which puts filing at provincial level in the first place. If you are planning a filing, the practical effect matters: the questions that come up along the way have no single national answer, and the answers you can get are provincial ones.
7. A few other points
Antibacterial preparations. Raw materials have to meet the hygiene standard for disposable sanitary products, GB 38456—2020, the 2009 good practice rules for disinfection product manufacturers, and the requirements set out in the 2003 document referenced by the NCDPA (卫法监发〔2003〕41号), among other instruments.
Labelling of paper products. Asked which paper products require a disinfection product manufacturer's hygiene licence number (commonly called 消字号), the NCDPA cited clause 3.12 of GB 38598—2020: the tissue paper category (纸巾（纸）) covers facial tissues, napkins, pocket tissues, hand towels and toilet paper, but not toilet tissue for lavatories.
Declaring a standard is not the NCDPA's business. Asked whether GB 15979—2024 should be declared on the packaging, the NCDPA first repeated that products not listed in the standard fall outside its scope, then said that declaring an enterprise or product standard is governed by the Standardization Law and belongs to the standardisation authorities. Other replies point to whoever owns the standard: GB/T 27728 to the China National Light Industry Council, GB 43631 to the Ministry of Industry and Information Technology, GB 18401 to its own technical committee.
Imports and the Hague Convention. Questions about the Apostille Convention go to the foreign ministry, not to the NCDPA.
GB 38456—2020 clause 4.3, which prohibits pharmacopoeia drugs and materials of the same name, is in force and correct as written.
The replies give a fair picture of how the rules are applied, and of which questions the regulator will not answer at national level. But each one was written for one product and one filing. Where your product or your filing turns on its own facts, the answer will come from the provincial disease control department where you file.
