Feminine Hygiene, Disinfectant, Antibacterial & Anti-inflammatory Products: Compliance Boundaries Analysis

With economic development, public attention to personal and intimate health has increased significantly, especially among women, who are breaking down traditional taboos and gaining a deeper understanding of intimate health. Against the backdrop of the rise of the "she-economy" and the post-90s and post-00s generations becoming the main consumers, feminine hygiene products are entering a period of rapid growth. Statistics show that the market size increased from 13.04 billion yuan in 2016 to 34.65 billion yuan in 2023, and is projected to reach nearly 45 billion yuan in 2026.

In the current booming market for intimate health products, product positioning confusion and overreaching efficacy claims have become the most frequent compliance pitfalls for companies. This article delves into three main categories—daily cleaning feminine hygiene products, antibacterial (antimicrobial) disinfectant feminine hygiene products, and anti-inflammatory feminine hygiene medications—to help you clarify compliance boundaries.

To gain a clearer understanding of these three types of products, we can first use a direct comparison to outline their core differences in key metrics 👇

Daily Cleansing Feminine Hygiene Products

According to relevant regulations, products such as washes (gels, suppositories) used for daily cleaning and care of the female vulva and vagina are not regulated as products falling under the categories of cosmetics, disinfectants, or medical devices because their characteristics do not meet the definitions of these categories.

Currently, these manufacturers and distributors typically conduct product research and development, production, and sales activities according to their self-developed technical specifications, ensuring that their products meet safety and usage requirements through a well-defined quality control system.

Antibacterial (bacteriostatic) disinfectant feminine hygiene products

Core Positioning

These products come into direct contact with the mucous membranes of the genital area, providing cleaning, antibacterial, and bacteriostatic effects, but do not have therapeutic functions.

Key Compliance Points for Labeling and Claims

The amendment to GB38598-2020, "General Requirements for Labeling and Instructions for Disinfectant Products," will be implemented on May 1, 2025. Based on the revised requirements, the key compliance points for labeling and efficacy claims of antibacterial agents are as follows:

1. Mandatory Warning Statement: The label must state, "This product is not a medicine and has no therapeutic, nursing, or health care effects" (font must be bold or larger than the instructions for use and general precautions).

2. Products specifically for vaginal mucosa should state: "Not for the prevention of sexually transmitted diseases during sexual intercourse."

3. Trademark Prohibitions: Trademarks that exaggerate functions or mislead consumers should not be used, such as those with homonyms or graphics that imply disease treatment, nursing, or health care effects.

4. Prohibited Claims:

• Anti-inflammatory, anti-inflammatory, treatment of diseases, reduction or relief of disease symptoms, description or explanation of disease symptoms, prevention of sexually transmitted diseases;

• Suitable for broken skin, broken mucous membranes, wounds, etc.;

• Highly effective, disinfectant, sterilizing, bactericidal, spermicide, contraceptive;

• A course of treatment is x days, or as directed by a physician: prevents recurrence; promotes wound healing; assists in drug treatment.

  
  

Testing Requirements

Antibacterial (antimicrobial) disinfectant feminine hygiene products must be tested in accordance with the relevant provisions of GB 15979-2024 "Hygienic Requirements for Disposable Sanitary Products" (implemented after July 1, 2025). Specific requirements are as follows:

Microbiological Testing: Testing for coliform bacteria, Staphylococcus aureus, and Candida albicans is required.

Toxicological Testing: A vaginal mucosal irritation test is required.

Anti-inflammatory Feminine Hygiene Products

Core Positioning

These products require approval from the drug regulatory authority and have disease treatment functions.

Key Labeling Points

The key labeling points for pharmaceutical products focus on indications or therapeutic functions, specifications, dosage and administration, adverse reactions, contraindications, and precautions. Taking the above-image "××" feminine wash as an example, its label clearly indicates key information such as adverse reactions (e.g., "burning sensation at the application site") and contraindications (e.g., "not for use during menstruation").

In the feminine hygiene market's booming growth phase, approaching a scale of 45 billion yuan, antibacterial feminine hygiene products are increasingly favored by consumers due to their better alignment with daily care needs. Compared to drug registration, antibacterial preparation registration has significant advantages in terms of lower investment costs and shorter processing times, a characteristic that is driving more companies to enter this field. Driven by this dual factor, only by proactively embracing compliance changes and responding to regulatory requirements can companies seize opportunities and lead the trend in industry competition.

If you have any questions related to China disinfectant products registration and filing, please contact us via info@enter-co.com.

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