Tampons are classified as medical or personal hygiene products, meaning they must meet strict safety, labeling, and quality regulations before reaching the market.
If you plan to launch or expand your tampon brand internationally, understanding FDA and CE requirements is essential for compliance and consumer trust.
This guide breaks down the key standards, certifications, and documentation you need to manufacture and sell tampons legally in the U.S., the European Union, and beyond.
Why Compliance Matters
Compliance is not just a regulatory formality — it’s a brand credibility factor.
Following FDA and CE guidelines ensures:
- Product safety and hygiene consistency
- Legal entry into regulated markets
- Protection against recalls or penalties
- Stronger trust among retailers and consumers
Failure to meet these requirements can lead to shipment delays, product bans, or reputation damage.
1. FDA Requirements (United States)
In the U.S., tampons are regulated by the Food and Drug Administration (FDA) as Class II medical devices under 21 CFR 884.5460.
Manufacturers must demonstrate safety, effectiveness, and compliance through several steps.
A. 510(k) Premarket Notification
Before selling tampons in the U.S., you must submit a 510(k) Premarket Notification to the FDA.
This document proves your product is substantially equivalent to an already cleared tampon on the market.
It typically includes:
- Product description and intended use
- Absorbency testing results
- Toxic Shock Syndrome (TSS) risk assessment
- Microbiological and biocompatibility test data
- Labeling and packaging information
Once cleared, your product receives an FDA 510(k) number for legal sale.
B. Labeling & Packaging Rules
FDA labeling standards require:
- Absorbency range clearly marked (e.g., Regular, Super, Super Plus)
- TSS warning and educational information
- Manufacturer or distributor name and contact address
- Batch or lot number for traceability
All information must appear in English and be legible on both the primary and secondary packaging.
C. Quality Control & Facility Registration
- All tampon manufacturing facilities must register with the FDA.
- Annual Device Listing is required to maintain active status.
- Quality systems should follow 21 CFR Part 820 (QSR) — the FDA’s quality management framework similar to ISO 13485.
👉 At TamponManufacturer.com, we support clients through the 510(k) process and FDA facility registration.
2. CE Requirements (European Union)
In the European market, tampons are regulated as medical devices under the EU Medical Device Regulation (MDR 2017/745).
A. Classification & Technical Documentation
Tampons are generally considered Class I medical devices, though classification can vary based on applicator design and claims.
To obtain CE marking, manufacturers must prepare:
- Technical file with material and safety data
- Risk management documentation (ISO 14971 compliance)
- Clinical or laboratory performance evaluation
- Labeling in all relevant EU languages
Once verified by a Notified Body, your product can display the CE mark and be sold across all EU countries.
B. Labeling Requirements
CE-compliant tampon packaging must include:
- CE mark and manufacturer’s name/address
- Product description and lot number
- Intended use and absorbency level
- Instructions for safe use and disposal
C. Post-Market Surveillance
EU manufacturers must monitor and record product performance through:
- Consumer feedback and complaint tracking
- Corrective and preventive action plans (CAPA)
- Annual safety update reports (PSUR)
This ensures continued compliance and consumer protection.
3. ISO & GMP Standards for Global Compliance
In addition to FDA and CE regulations, most professional tampon manufacturers follow international standards, including:
- ISO 13485: Quality management for medical devices
- ISO 22716: Good Manufacturing Practice (GMP) for cosmetics and hygiene products
- ISO 14971: Risk management for medical device production
Following these frameworks enhances credibility and simplifies entry into multiple markets.
4. How a Professional Manufacturer Helps
Navigating compliance alone can be overwhelming. Partnering with an experienced manufacturer ensures your products meet every requirement efficiently.
At TamponManufacturer.com, we offer:
- Full documentation support (FDA 510(k), CE technical files)
- Material safety and absorbency testing
- Private label registration assistance
- Production under ISO-certified facilities
Our compliance experts ensure that every tampon you produce is safe, legal, and market-ready.
Final Thoughts
Regulatory compliance is the foundation of a trustworthy tampon brand.
Whether you plan to sell in the U.S., Europe, or globally, understanding FDA and CE requirements is essential to avoid delays and build consumer confidence.
👉 Ready to bring your compliant tampon brand to market?
Contact TamponManufacturer.com to get expert guidance on FDA/CE certification and private label manufacturing.