Submitting a disinfection product filing (卫生安全评价备案) to China‘s National Disinfection Product Online Filing Information Platform is a critical step for any manufacturer or importer wishing to sell disinfectants, antimicrobial wipes, or disinfection devices in China. Despite the availability of clear guidelines under WS 628-2018, a surprisingly high percentage of first‑time submissions are rejected or returned for corrections – often causing delays of 2‑5 months. Understanding the top reasons for disinfection product filing rejection can help you avoid these pitfalls and achieve first‑time approval. This guide details the most common failures and provides actionable fixes.
1. Incorrect Product Classification – Disinfectant vs. Antimicrobial vs. Device
China’s disinfection product regulatory system distinguishes between disinfectants (liquid, gel, powder for surface disinfection), disinfection devices (machines generating sterilizing factors), antimicrobial products (antibacterial wet wipes, hygiene products), and other hygiene products (ordinary wet wipes, sanitary pads). Each category has different testing requirements, labeling rules, and filing pathways. Common classification errors include:
- Filing an antibacterial wet wipe as a disinfectant – antibacterial wet wipes require only limited efficacy tests, but if filed as a disinfectant, the entire battery of disinfectant tests (including sporicidal activity) would be needed, leading to rejection for missing data.
- Filing a disinfection device under the disinfectant category – devices must provide equipment safety and performance data, not just chemical test reports.
- Assuming that a product with the same name as a previously approved product belongs to the same category – formulation changes may push the product into a different regulatory scope.
How to fix: Before filing, carefully review the “Definition of Disinfection Products” under the Disinfection Measures and WS 628-2018 Appendix A. If uncertain, apply for a classification consultation with the local health authority. Once the correct category is identified, compile the specific dossier required for that product type.
2. Incomplete, Invalid, or Outdated Test Reports
Test reports are the backbone of the filing dossier. Rejections frequently occur because:
- Missing required test items: For disinfectants, the mandatory tests include active ingredient content, pH, stability (at least two batches, covering the claimed shelf life), microbiological efficacy (≥5.00 log reduction for bacteria), toxicology (acute oral toxicity, skin irritation, mutagenicity), and metal corrosion (for products used on metal surfaces). Many applicants omit metal corrosion or stability tests.
- Test reports from non‑CNAS accredited labs: Only reports from laboratories accredited by CNAS (China National Accreditation Service) for the specific test methods are accepted. A report from a foreign ISO 17025 lab without CNAS endorsement will be rejected.
- Expired test reports: Test reports are generally valid for 3 years from the date of issue. Reports older than 3 years are not accepted unless a full re‑test is performed.
- Sample not representative of production batch: The tested sample must come from normal production; lab‑scale preparations or specially “golden” samples are not allowed. The batch number must appear on the test report.
- Missing raw data or test conditions: Reports that only give summary conclusions (e.g., “pass”) without listing test concentrations, exposure times, and temperature/humidity conditions are considered incomplete.
How to fix: Engage a CNAS‑accredited lab early. Provide a clear test plan listing all required items per WS 628-2018. Use production‑scale samples. Request full reports including raw data. Schedule re‑tests if reports are near expiry.
3. Labeling and Instruction Non‑Compliance (GB 38598-2020 & Amendment No.1)
Label errors are a leading cause of filing rejection. Under GB 38598-2020 (and its 2025 Amendment No.1), the following mistakes are common:
- Missing mandatory warnings: For antibacterial products, the statement “This product is not a drug and does not have therapeutic, nursing or health care effects” is required. For vaginal mucosal products, an additional warning about STD prevention is required. Omitting these leads to immediate rejection.
- Font height below 1.8 mm: All Chinese characters, numbers, and letters must have a font height of at least 1.8 mm. Many imported products use smaller fonts to fit multiple languages.
- No filing number on label: The filing certificate number (备案凭证编号) must be displayed on the sales package label. Submitting a label without it is a common oversight.
- Missing product name consistency: The product name on the label must match the name in the test reports, formulation, and application form exactly – including spaces, punctuation, and case.
- Prohibited claims: Any therapeutic claim (e.g., “anti‑inflammatory,” “treats infections”), drug names, or misleading graphics are strictly forbidden.
- Absence of expiry date in YYYY‑MM‑DD format: The date must be clearly printed.
How to fix: Create a label template that includes all mandatory fields, then have it reviewed by a regulatory specialist. Use the exact wording from GB 38598-2020 for warnings. Ensure font height is verified with a ruler. Remove any prohibited phrases. Print a proof label and include it in the submission.
4. Missing or Inaccurate Formulation Disclosure
For disinfectants and antimicrobial products, the complete formulation (all ingredients with their CAS numbers and concentrations) must be submitted. Rejections occur when:
- Only active ingredients are listed: The formulation must include all inactive ingredients (fillers, stabilizers, surfactants, preservatives, fragrances). Failure to disclose any component is considered a major deficiency.
- Percentage concentrations not provided: Each component must be given as mass/volume percentage (w/w or w/v) or as a range, but the range must be narrow enough to guarantee efficacy and safety.
- Ingredient not allowed in China: Some ingredients that are permitted in other countries are restricted or prohibited in China (e.g., certain quaternary ammonium compounds at high concentrations, specific fragrances). The reviewing authority will check each ingredient against the positive lists.
- Trade names instead of chemical names: The dossier must use standard chemical names (INCI or IUPAC) or the names as listed in China‘s Inventory of Existing Disinfection Product Ingredients. Trade names or proprietary codes are not accepted.
How to fix: Obtain a complete formulation from your supplier in Chinese or in a bilingual format. Cross‑check each ingredient against China’s permitted lists. Use the exact concentration values as used in the manufacturing batch. If the formula is proprietary, you may submit it under confidentiality, but the full disclosure is still required for review. Engage a local chemist to verify compliance.
5. Stability Test Gaps – Shelf Life Not Fully Verified
Stability testing is often mishandled, leading to rejection. Common issues include:
- Stability tests performed only on one batch: WS 628-2018 requires at least two batches for stability, covering the entire claimed shelf life.
- Accelerated stability data used without real‑time data for final approval: For initial filing, accelerated testing (e.g., 54°C for 14 days) may be accepted as a provisional shelf life, but the filing will be conditional and require real‑time data later. Many applicants fail to submit the real‑time follow‑up, causing eventual rejection.
- Test conditions not documented: Storage temperature, humidity, and packaging must be specified. Without this, the report is invalid.
- Shelf life longer than supported by data: If test data only covers 12 months, the label cannot claim a 24‑month shelf life.
How to fix: Plan stability testing at the start of product development. Use at least two batches from pilot or full production. Submit both accelerated (if applicable) and real‑time data for the claimed shelf life. Ensure the test report clearly states the storage conditions and the batch numbers.
6. Missing or Invalid Enterprise Hygiene License (for domestic manufacturers) / Agent Documentation (for imported products)
For imported products, the China agent (responsible party) must provide:
- Power of Attorney (POA) – Notarized, legalized (or apostilled), and translated into Chinese, authorizing the agent to represent the foreign manufacturer.
- Agent‘s business license – Showing that the agent is a legal entity in China with the appropriate business scope (e.g., “disinfection product consulting” or “import/export”).
- Proof of legal sale in the country of origin – For disinfectants, a free sale certificate or certificate of pharmaceutical product is required. Many applicants submit an outdated certificate or one that does not list the exact product name.
If any of these documents are missing, expired, or improperly executed, the filing will be rejected.
How to fix: Engage a qualified China agent with experience in disinfection products. Prepare the POA months in advance, as notarization and legalization can take 2‑4 weeks. Obtain the free sale certificate from the exporting country’s health authority; ensure it matches the product name and formulation. Keep all documents in a secure file and check expiry dates.
7. Inconsistent Information Across the Dossier
The filing application, test reports, label, instruction manual, and formulation must all be internally consistent. Common inconsistencies include:
- Product name mismatch: The label says “XYZ Antibacterial Wipes” but the test report says “XYZ Wipes” – the reviewer will reject for inconsistency.
- Batch number discrepancy: The test report references batch “20251201”, but the stability report and formulation refer to batch “20251201A”.
- Active ingredient concentration differences: The formulation says 0.5% benzalkonium chloride, but the test report used a sample with 0.55% – this indicates lack of batch representativeness.
- Manufacturer address variation: The label shows “No. 5 Factory Road, City A” while the free sale certificate shows “5 Factory Road, City A” – even minor differences cause rejection.
How to fix: Use a master data sheet to define the exact product name, model, batch number, manufacturer details, and agent details. Copy‑paste from this sheet into every document. Designate one person to perform a consistency check across all files before submission.
8. Online Filing Platform Submission Errors
The National Disinfection Product Online Filing Information Platform has specific technical requirements. Rejections can occur due to:
- Scanned documents not in PDF/A format or too large in size. The platform has file size limits (e.g., 20 MB per file).
- Missing electronic signatures or seals. Certain documents require an electronic signature from the agent or the manufacturer.
- Incomplete categorization of product type. Selecting the wrong category from the dropdown menu leads to routing to the wrong review team.
- Failure to submit the filing after pre‑review. Some applicants upload documents but forget to click “Submit”.
How to fix: Before final submission, test‑upload a sample file to ensure size and format compliance. Consult the platform‘s user manual. Have a team member double‑check that the product category is correctly selected. After uploading all documents, verify that the submission status says “Submitted”.
9. Language and Translation Errors (for Imported Products)
All documents must be in simplified Chinese or accompanied by a certified Chinese translation. Common mistakes:
- Machine‑translated test reports or labels: Technical terms like “virucidal activity” or “log reduction” are often mistranslated, causing confusion.
- Inconsistent translation of key terms: The same chemical name translated differently in the formulation and the label.
- Missing translation of foreign free sale certificate: Even if the original is in English, a certified Chinese translation is required.
How to fix: Hire a professional translator with experience in disinfection product regulations. Provide a glossary of terms to ensure consistency. Have a second translator proofread all documents. Attach a certification statement with each translation.
10. Pre‑Submission Checklist for Disinfection Product Filing
To avoid the most common rejection reasons, use this checklist before submitting your filing:
- [ ] Product classification verified (disinfectant / device / antimicrobial / hygiene).
- [ ] Test reports from CNAS‑accredited lab, covering all required items (efficacy, toxicology, stability, metal corrosion).
- [ ] Reports issued within 3 years, with full raw data and batch information.
- [ ] Formulation disclosed completely (active + inactive ingredients, CAS numbers, concentrations).
- [ ] Label meets GB 38598-2020 & Amendment No.1 (font ≥1.8mm, warnings present, no therapeutic claims).
- [ ] Instruction manual in simplified Chinese, consistent with label.
- [ ] Filing number (after approval) will be added – placeholder accepted for submission but must be added before printing.
- [ ] China agent POA notarized, legalized, translated, and valid.
- [ ] Free sale certificate (for imported products) current and matching product name.
- [ ] All documents consistent (product name, batch number, manufacturer details).
- [ ] Files in PDF/A format, within size limits, correctly uploaded and submitted.
Summary: Top reasons for disinfection product filing rejection – classification errors, incomplete test reports, labeling non‑compliance, missing formulation details, stability gaps, agent documentation issues, inconsistency, platform errors, and translation mistakes – are all preventable with careful preparation. By following the pre‑submission checklist and working with qualified CNAS labs and experienced China agents, you can achieve first‑time approval and bring your products to market without costly delays. Early investment in proper documentation pays off many times over.