New Labeling Guidelines for Imported Disinfection Products | China 2026 Compliance

Since the full implementation of WS 628-2018 (Hygienic Safety Evaluation Technical Requirements for Disinfectants) and GB 38598-2020 (General Requirements for Labeling and Instructions of Disinfection Products), Chinese customs and health authorities have significantly strengthened inspections on imported disinfection products. The introduction of Amendment No. 1 to GB 38598-2020 on May 1, 2025, further tightened labeling requirements, particularly for antibacterial and bacteriostatic products. For importers of disinfectants, disinfectant devices, and antimicrobial products, understanding these new labeling guidelines for imported disinfection products is critical to avoid customs holds, fines, and market access denials. This guide provides a comprehensive overview of mandatory label elements, common compliance failures, and a practical roadmap to achieve first‑time approval.

1. Core Regulatory Framework

The labeling of imported disinfection products in China is governed by three key documents. WS 628-2018 specifies the complete hygienic safety evaluation dossier, which includes product labeling as a mandatory component. GB 38598-2020 is the mandatory national standard that defines the specific content requirements for labels and instructions. Amendment No. 1 to GB 38598-2020, effective May 1, 2025, introduced strengthened requirements for antibacterial products, font height specifications, and brand name restrictions. Imported products must comply with these standards before clearance. Enforcement is rigorous: according to customs data, unlabeled products or those with non‑compliant labels face direct detention or destruction, and the absence of a valid filing record leads to refused clearance.

2. Mandatory Label Elements for Different Product Types

2.1 Disinfectants – Minimum Sales Packaging Label

The label on the smallest sales package of a disinfectant must include: product name; health approval certificate number; net content; product specification (for tablet forms); main active ingredient and its concentration; scope of use (for mucosal disinfectants, the statement “For medical institution use only” is required); production date and expiry date; manufacturer name, address, and contact information; manufacturer‘s health license number (for domestic products); country of origin (for imported products); and storage conditions. Each of these elements is mandatory, and any omission results in rejection.

2.2 Disinfectant Devices – Nameplate and Instruction Manual

For imported disinfectant devices, the nameplate must include the product name; health approval certificate number; main technical parameters; main sterilizing factor and its intensity (not required if no test method exists); application time and applicable area or volume; batch number; production date; overall service life or service life of main components; manufacturer name and address; manufacturer‘s health license number (for domestic products); and country of origin.

The instruction manual must include: product name; health approval certificate number; model number; mechanism of action; main sterilizing factor and intensity; category of sterilized microorganisms; scope of use; application methods; precautions; overall service life or service life of main components; applicable standard number; manufacturer name, address, and contact information; manufacturer‘s health license number (for domestic products); and country of origin. Importers should ensure that the Chinese instruction manual is provided with each unit or as a digital download accessible via a QR code on the packaging.

2.3 Hygiene Products – Wet Wipes, Sanitary Pads and Antimicrobials

Hygiene products have distinct labeling requirements. For wet wipes (ordinary, not antimicrobial), the label must include product name, net content, manufacturer name and address, manufacturer‘s health license number, country of origin (for imported products), production date and shelf life or batch number and expiry date, storage conditions, product specification, main raw material names, and applicable standard number. For antimicrobial wet wipes (卫生湿巾), additional elements are mandatory: the main active ingredient content in the expressed liquid, category of sterilized microorganisms, and scope of use. For antimicrobial products targeting vaginal mucosa, the label must also bear the statement “Not for use in prevention of sexually transmitted diseases during sexual intercourse.”

3. 2025 Amendment No. 1: Key New Requirements

The May 2025 amendment to GB 38598-2020 introduced three critical changes that all importers must address. For antibacterial and bacteriostatic products, a new mandatory warning must now appear on the label: “This product is not a drug and does not have therapeutic, nursing or health care effects.” If the product is intended for vaginal mucosa, an additional warning is required: “Not for use in prevention of sexually transmitted diseases during sexual intercourse.” The warning font must be either boldface or have a larger font size than the “Directions for use” and other general precaution text. Font height requirements were also updated: all Chinese characters, ethnic minority scripts, numbers and letters must have a font height of at least 1.8 mm (previously >1.8 mm). For brand names and trademarks, the use of homophones or graphics that suggest therapeutic, nursing or health care functions is now strictly prohibited. These revisions took effect on May 1, 2025. Products manufactured or imported after this date must comply. Products produced or imported before May 1, 2025 may be sold under the old standard until their labelled expiry date.

4. Prohibited Content – The Absolute “Red Lines”

Under WS 628-2018 and GB 38598-2020, disinfection product labels must not contain any content that is false, exaggerated, or suggests therapeutic efficacy. Absolute prohibitions include any statement that explicitly or implicitly suggests therapeutic effects on diseases—this includes terms such as “treat”, “cure”, “anti‑inflammatory”, “pain relief”, “relieve symptoms”, “100% sterilization”, or any reference to specific disease names; any implication of preventive effects on sexually transmitted diseases; any drug names, antibiotic names, hormone names, or antifungal agent names; any recommendation by government agencies or claims such as “academician recommended” or “NHC certified”; any instructions for use on prohibited body sites, including foot, eye, nail, armpit, scalp, hair, nasal mucosa or anal and rectal areas; any description suggesting the product may be used as a drug, including phrases like “X days as one course of treatment” or “use as directed by physician”; any representation that mimics drug packaging or drug names that may cause consumer confusion; and for antimicrobial wet wipes, the term “antibacterial” is itself prohibited. These are mandatory compliance requirements—any violation results in immediate rejection.

5. Import‑Specific Requirements

For imported disinfection products, the China agent (Responsible Party / Product Responsibility Unit) must complete the hygienic safety evaluation and submit the filing through the National Disinfection Product Online Filing Information Platform before any product can be legally imported or sold. The filing dossier includes the product label and instructions (must comply with GB 38598-2020 and Amendment No. 1), test reports (efficacy, toxicology, stability), product formulation (for disinfectants and antimicrobials), quality standards, and proof of legal sale in the country of origin. The filing number and the China agent‘s name and address must appear on the product label. Without a valid filing record, customs will not release the shipment.

6. Common Labeling Failures and How to Fix Them

Based on regulatory enforcement data, the most frequent labeling violations for imported disinfection products include:

• Missing mandatory warnings: For antibacterial products, the required warning that the product is not a drug is often omitted. Including the exact wording is mandatory.
• Font height below 1.8 mm: Many imported products use small‑font labels to fit multiple languages. Ensuring the minimum font height is essential.
• Therapeutic claims: Terms like “anti‑inflammatory” or “relieves itching” appear even on products that would otherwise be compliant. Such terms must be removed entirely.
• Inconsistent product naming: The product name on the label must match the name in the filing, test reports, and customs declaration exactly.
• No filing number on the label: The filing certificate number (备案凭证编号) is mandatory on the label. The label is incomplete without it.
• Missing China agent information: The agent‘s name and address must appear exactly as registered.

7. Pre‑Import Label Compliance Checklist

Before shipping any disinfection product to China, verify label compliance using this checklist:

• [ ] Product name matches the filing certificate exactly.
• [ ] Filing certificate number displayed in correct format.
• [ ] Main active ingredient and concentration declared.
• [ ] Scope of use clearly stated (with mucosal disinfection statement if applicable).
• [ ] Production date and expiry date in YYYY‑MM‑DD format.
• [ ] Manufacturer‘s name and address (in Chinese).
• [ ] China agent‘s name and address correctly displayed.
• [ ] Country of origin clearly indicated.
• [ ] For antibacterial products: required warning present in boldface or larger font.
• [ ] Font height ≥ 1.8 mm for all Chinese characters and numbers.
• [ ] No therapeutic claims (e.g., “anti‑inflammatory”, “treat”, “cure”).
• [ ] No drug ingredients (antibiotics, hormones) declared.
• [ ] For mucosal disinfectants: “For medical institution use only” statement.
• [ ] For vaginal antimicrobials: additional STD prevention warning.
• [ ] Brand name compliant with Amendment No.1 (no misleading homophones or graphics).

8. Real‑World Case – Label Non‑Compliance Leads to Shipment Hold

A European disinfectant importer shipped a container of antibacterial surface wipes to Shanghai. The Chinese label had the active ingredient declaration, production dates, and manufacturer information. However, the importer missed two critical elements: the warning statement “This product is not a drug and does not have therapeutic, nursing or health care effects” was entirely absent, and the label claimed “eliminates 99.99% of bacteria” without the required qualifying context. Customs detained the shipment and required re‑labeling at the port – a process that took 6 weeks and cost $12,000 in storage fees and labor. The total market entry delay was 4 months. Lesson: every mandatory element must be present, and every claim must be verifiable.

9. Step‑by‑Step Compliance Roadmap for Importers

To successfully navigate the labeling and filing requirements for imported disinfection products, follow this five‑phase plan:

1. Engage a China agent: Appoint a local responsible party to file the product and hold the certificate. The agent‘s name and address will appear on the product label.
2. Determine product classification: Identify whether the product is a disinfectant (liquid/gel), disinfectant device (machinery), or hygiene product (wipes, pads). Classification determines applicable test requirements.
3. Conduct required tests: Work with a CNAS‑accredited lab to complete efficacy testing (microbial log reduction), toxicology testing, stability testing, and any product‑specific tests (e.g., corrosion for devices). Use the same batch for all tests.
4. Prepare the filing dossier: Compile the label artwork, instruction manual, test reports, quality standards, formulation (for disinfectants), and proof of legal sale in the country of origin. Translate all documents into simplified Chinese (certified).
5. Submit filing and print labels: Submit the dossier through the National Disinfection Product Online Filing Information Platform. After approval (typically 5‑20 working days), obtain the filing certificate number. Print the final labels with the certificate number and all mandatory content. Ensure label artwork matches the filed version.

Summary: New labeling guidelines for imported disinfection products under WS 628-2018 and GB 38598-2020 (including Amendment No. 1, effective May 2025) mandate strict compliance for disinfectants, disinfectant devices, and hygiene products. Mandatory elements vary by product type, but all require a Chinese label with the filing number, active ingredients, production and expiry dates, manufacturer and China agent information, and required warnings. Amendment No. 1 adds a critical child safety warning for antibacterial products, increases minimum font height to 1.8 mm, and restricts misleading brand names. Prohibitions include any therapeutic claims, drug ingredient references, or off‑label body sites. By following the pre‑import checklist and engaging a qualified China agent, importers can achieve smooth customs clearance and maintain market access for disinfection products in China‘s rapidly growing public health market.