Buyer Summary
Use this page as a fast supplier screen before you ask for pricing. Compare material documentation, product structure, sampling discipline, packaging capability, QC release, and export document readiness. The goal is not to find the lowest unit price. The goal is to find a supplier whose quoted material, dimensions, hardness, packaging, inspection criteria, and documentation can survive your destination-market review. A low quotation without these fields is not comparable. Final market claims remain the buyer’s responsibility.
Supplier Screen
A menstrual cup is not a generic silicone accessory. It is a sensitive-care product with direct vaginal contact, repeat-use expectations, cleaning instructions, size logic, and market-specific claim requirements. Because of that, a supplier screen should happen before a detailed price negotiation. If you compare only unit price, you may miss the differences that create recalls, delays, rejected shipments, or regulatory friction later.
Use this screen to separate suppliers that can answer technical questions from suppliers that only send a price list. A capable OEM partner should be able to explain the quoted material, size logic, hardness direction, packaging components, inspection criteria, and which claims still require target-market verification. The supplier does not need to approve your market claims for you. In most cases, the buyer remains responsible for final regulatory and advertising claims. But a good supplier should help you identify what evidence exists, what evidence is missing, and what must be confirmed before launch.
Fast supplier screen
Before requesting pricing, ask for these minimum fields. If a supplier cannot provide them in writing, treat that as an early warning.
- Quoted material specification and applicable test scope
- Quoted dimensions and verified capacity data
- Sample approval before mass production
- Packaging and instruction leaflet support
- QC release fields and approved evidence status
- Clear RFQ response path
A useful supplier response should identify the material grade, the proposed product structure, the size range, the hardness direction, the packaging format, the sample path, the QC release format, and the export document set. It should also state clearly which items are standard, which are customized, and which require project-specific confirmation.
Do not compare suppliers by unit price alone
Unit price is easy to compare. Technical readiness is not. Two quotations for “medical-grade silicone menstrual cups” may look similar on a spreadsheet while representing very different levels of risk. One quote may include a documented material grade, controlled colorants, verified dimensions, sample approval, leaflet review, and final QC release. Another may include only a mold estimate and a bulk price. These are not comparable quotations.
A menstrual cup supplier should be able to explain:
- What material is quoted, and how changes to that material are controlled
- Why the quoted sizes exist, and how capacity is measured
- What hardness or product-feel direction is intended
- How color, logo, pouch, box, leaflet, and starter kit components are handled
- Which inspection criteria are used at final release
- Which documents are available for review, and which must be confirmed per project
- Which claims require destination-market verification by the buyer
A low quotation can be legitimate, but it should still answer these questions. If it does not, the buyer is not comparing suppliers. The buyer is comparing unknowns.
Supplier comparison table
| Evaluation criterion | What good looks like | Red flag |
|---|---|---|
| Material identity | Written material name, grade, supplier, cure system, and change-control path | “Silicone” only, with no grade or supplier detail |
| Product structure | Cup shape, rim, stem, wall, dimensions, and size logic explained | No drawings, no size rationale, no structure options |
| Capacity data | Verified capacity stated with measurement method | Capacity claimed without method or sample verification |
| Hardness / feel | Hardness direction stated as measured value, product feel, or both | Vague “soft” or “firm” with no measurable reference |
| Sampling discipline | Catalog, paid, prototype, and approval samples defined before mass production | Mass production expected without golden sample approval |
| Packaging capability | Pouch, box, leaflet, logo, starter kit, and artwork proof support | Packaging treated as an afterthought after price agreement |
| QC release | Defined release fields, inspection evidence, and nonconformance process | “We check quality” with no release template |
| Documentation | Material, test, QC, packaging, and export files mapped per project | Certificates promised generically without project confirmation |
| Export readiness | Commercial invoice, packing list, HS code support, COA, and test reports discussed | No document list, no handover responsibilities |
| Claims support | Supplier identifies evidence gaps and buyer verification needs | Supplier promises market claims without proof |
| MOQ logic | Per-SKU MOQ after color, packaging, tooling, and customization are defined | MOQ changes after sampling or artwork approval |
| Schedule discipline | Dated plan after approvals, deposit, and delivery terms are agreed | Verbal lead time only, no dated production plan |
Material and document checklist
Material documentation is the foundation of a credible OEM project. For menstrual cups, buyers commonly ask about medical-grade liquid silicone rubber (LSR) , platinum-cured silicone, and USP Class VI material claims. These are industry-typical reference points, not automatic claims about any specific supplier. Document availability must be confirmed per project with YUJI or any other supplier under evaluation.
Use the table below as a checklist during supplier review.
| Item | What to request | Why it matters |
|---|---|---|
| Material specification | Grade, supplier, cure system, lot traceability, and change-control statement | Confirms what is actually quoted and how changes are managed |
| Biocompatibility tests | ISO 10993 scope, including vaginal irritation , skin sensitivity , cytotoxicity , or other applicable tests | Helps buyer assess whether the material is suitable for vaginal-contact use |
| Quality system documents | ISO 13485 , ISO 9001 , or other QMS evidence available for review | Shows whether the factory has a structured quality system |
| Regulatory support | CE technical-file support for Class I menstrual devices where applicable | Clarifies what the supplier can provide for European market review |
| U.S. market registration | FDA establishment registration (registration, NOT 510(k) clearance ) | Distinguishes facility registration from product clearance |
| Per-lot testing | SGS per-lot test reports or equivalent third-party reports | Supports incoming and release review for bulk orders |
| Restricted substances | REACH / RoHS statements or test reports where relevant | Helps buyer screen material compliance for target markets |
| Colorants and additives | Colorant supplier, migration control, and vaginal-contact suitability | Prevents undocumented additives from entering the finished product |
| Dimensions | Rim diameter, cup height, stem length, wall thickness, and tolerances | Creates a measurable basis for sample approval and QC |
| Capacity | Verified capacity data and measurement method | Avoids mismatches between marketing claims and product performance |
| Hardness / feel | Measured hardness or product-feel target, plus sample approval criteria | Aligns buyer expectations with factory production reality |
| Packaging | Pouch, box, leaflet, label, logo, starter kit, and artwork proof | Confirms the supplier can support retail-ready delivery |
| Instruction leaflet | Language, warnings, symbols, cleaning instructions, and traceability code | Reduces labeling errors and market-specific compliance risk |
| QC release | Inspection report fields, AQL or sampling plan, and nonconformance process | Defines what “approved” means before shipment |
| Export documents | Commercial invoice, packing list, HS code support, COA, and test reports | Supports customs clearance and buyer documentation |
| Claims review | List of claims requiring buyer verification for the destination market | Keeps final market claims with the buyer, where they belong |
Industry-typical timeline benchmarks
The timeline below uses public competitor factory website ranges as industry-typical benchmarks. These are not YUJI-specific commitments. Every project must be scheduled after material, color, packaging, tooling, approval, and delivery requirements are defined. All numerical ranges below are to be confirmed per supplier and project.
| Stage | Industry-typical benchmark | What the buyer should confirm |
|---|---|---|
| Catalog OEM samples | 7–14 days | Sample availability, courier cost, and whether samples are free or paid |
| Paid sample set | 3–10 pieces , often quoted separately | Sample quantity, color, packaging mock-up, and test scope |
| Paid sample lead time | 7–15 business days | Whether sample fee is credited against bulk order |
| Prototype-mold samples | 15–25 days | Mold complexity, T1/T2 samples , and approval criteria |
| Catalog OEM bulk production | 25–40 calendar days after packaging approval and deposit | Deposit terms, packaging approval date, and ex-works handover |
| Approved production tooling bulk | 30–45 days ex-works | Tooling sign-off, production capacity, and inspection release |
| Catalog OEM with existing pack art | 4–8 weeks to first ship after PO | Artwork readiness, deposit, and shipping method |
| New-mold ODM | 8–12 weeks for tooling, T1/T2 samples , FAI sign-off | Tooling ownership, modification rounds, and final approval path |
The purpose of this table is not to lock in a schedule. It is to help buyers spot unrealistic promises. If a supplier quotes a new custom mold project with the same lead time as a catalog SKU, ask why. If sampling is skipped entirely, ask how golden sample approval will happen. If packaging approval is not tied to the production plan, expect delays.
Questions to ask before sampling
The original six questions remain the core of the pre-sampling review. Expand them into a fuller discussion before you invest in tooling or artwork.
- Which existing cup structures are available, and which need development? Ask for drawings, size range, stem options, rim profiles, and whether the structure is catalog OEM or new development. A supplier should be able to show what can be quoted immediately and what requires mold work.
- What are the quoted dimensions, verified capacity data, stem style, and product-feel or measured hardness requirements? Do not accept “small, medium, large” without dimensions and capacity verification. Ask how capacity is measured and how hardness is checked.
- Can the factory support color, logo, pouch, box, leaflet, and starter kit packaging? Packaging is part of the product experience. Confirm whether the supplier can handle artwork proofing, printing, language versions, and component assembly.
- Which material, testing, sterilization-related, and QC records can be reviewed? Ask for a document list, not a vague promise. Industry-typical certifications buyers ask about include ISO 13485 , ISO 9001 , ISO 10993 , CE technical-file support for Class I menstrual devices , FDA establishment registration (registration, NOT 510(k) clearance ), SGS per-lot test reports , REACH , and RoHS . Confirm availability per project with YUJI.
- What sample approval steps happen before artwork and mass production? Define the sample sequence: catalog sample, paid sample set, prototype sample, T1/T2 sample , and golden sample. State who approves, what is retained, and how changes are controlled.
- Which claims must the buyer verify for the destination market? The supplier can provide material and test documentation, but the buyer should verify final regulatory, advertising, and labeling claims for the target country.
Twenty-question supplier scorecard
Use this scorecard in your supplier discussions. It is grouped by category so teams can assign owners to material, quality, packaging, and logistics questions.
Material and product structure
- What is the exact quoted material identity, grade, supplier, and lot-traceability path?
- Is the material medical-grade liquid silicone rubber (LSR) , platinum-cured silicone, or another elastomer, and what is the stated cure system?
- Which material or finished-product tests apply: ISO 10993 , USP Class VI , vaginal irritation , skin sensitivity , cytotoxicity , or other biocompatibility scopes?
- How are colorants, pigments, and masterbatch controlled for vaginal-contact safety and migration?
- What is the change-control process if the material supplier, formula, or cure system changes after approval?
- What dimensions are quoted, what capacity data is verified, what stem style is proposed, and what hardness or product-feel direction is required?
MOQ and pricing
- What is the written per-SKU MOQ after color, packaging, tooling, and customization requirements are defined?
- What cost drivers are separated in the quote: material, tooling, sampling, packaging, printing, testing, freight, and documentation?
Sampling
- What is the sampling sequence: catalog sample, paid sample set, prototype-mold sample, T1/T2 sample , and golden sample approval?
- How many sample pieces are recommended for internal review, user trial, and retained reference?
- What sample approval steps happen before artwork release and mass production?
QC
- What QC release fields appear on the inspection report: dimensions, hardness, visual defects, capacity, packaging, and labeling?
- Which in-process and final-release checks are performed, and what sampling or inspection plan is used?
- How are nonconforming units, rework, and deviation approvals documented before shipment?
Packaging
- Can the factory support color, logo, pouch, box, leaflet, and starter kit packaging?
- Which instruction leaflet languages, warnings, symbols, and traceability codes can be printed and verified?
Documents
- Which material, testing, sterilization-related, and QC records can be reviewed for this project?
- Which claims must the buyer verify for the destination market, and which evidence gaps remain?
Logistics
- What export document set is available: commercial invoice, packing list, HS code support, COA, and test reports?
- What shipping terms, lead-time assumptions, and handover responsibilities are stated in the quote?
Recommended RFQ message
A good RFQ gives the supplier enough information to return a comparable response instead of a generic price list. Include your target country, sales channel, cup sizes, quantity, color direction, logo placement, pouch or box requirements, instruction language, launch date, and evidence needed. If you already have packaging dimensions, artwork status, or sample approval criteria, include those as well.
A useful RFQ structure:
- Company and market: Target country, sales channel, and intended user segment.
- Product: Menstrual cup, disc, pad, liner, or kit; catalog OEM or new development.
- Sizes and quantities: Size range, per-SKU quantity, and expected repeat order pattern.
- Color and branding: Color direction, logo placement, and whether custom color matching is required.
- Packaging: Pouch, box, leaflet, label, starter kit, and artwork readiness.
- Language and claims: Instruction leaflet language and any claims requiring verification.
- Timeline: Desired sample date, approval date, launch date, and delivery terms.
- Evidence: Material documents, test reports, QC template, and export documents needed for review.
When the supplier responds, compare the answer against the supplier comparison table and the twenty-question scorecard. If a quotation does not answer the material, QC, packaging, and documentation questions, do not treat it as a final price.
FAQ
What should I send in an RFQ for menstrual cups?
Send target country, sales channel, cup sizes, quantity, color direction, logo placement, pouch or box requirements, instruction language, launch date, and evidence needed. Add packaging dimensions, artwork status, and sample approval criteria if available. This helps the supplier return a comparable quotation.
Is unit price enough to compare OEM suppliers?
No. Unit price alone does not show material grade, change control, sample approval, QC release, packaging readiness, or export documentation. A low price without these fields is not comparable to a fully documented quotation.
What MOQ is typical for menstrual cup OEM?
Catalog OEM cups and discs often start around 500 units per SKU . Custom printed cartons or pouches often start around 500+ units per design . New custom molds are usually discussed at 500+ units to amortize tooling. Treat these as industry-typical benchmarks and confirm with each supplier.
How long does sampling take?
Catalog samples are often quoted at 7–14 days . Paid samples of 3–10 pieces may take 7–15 business days . Prototype-mold samples may take 15–25 days . Confirm the exact schedule after material, color, and packaging requirements are defined.
Which certifications or tests should buyers ask about?
Industry-typical certifications and tests buyers ask about include ISO 13485 , ISO 9001 , ISO 10993 , CE technical-file support for Class I menstrual devices , FDA establishment registration (registration, NOT 510(k) clearance ), SGS per-lot test reports , REACH , and RoHS . These are reference points, not automatic supplier claims. Confirm document availability per project with YUJI.
Does FDA establishment registration mean FDA clearance?
No. FDA establishment registration is not the same as 510(k) clearance . Buyers should confirm what registration or listing evidence is actually available and what their own U.S. market pathway requires.
Can the supplier confirm claims for my market?
The supplier can provide material specifications, test reports, QC records, and packaging files where available. The buyer is responsible for verifying final regulatory, advertising, and labeling claims for the destination market. Ask the supplier to identify evidence gaps early.
What documents should be approved before mass production?
Before mass production, approve the golden sample, material specification, artwork proof, packaging components, instruction leaflet, QC release template, and any available test reports. Confirm the production schedule after these approvals and deposit terms are agreed.
Next step
Do not start with “What is your best price?” Start with the supplier screen. Send your target market, product structure, size range, packaging direction, quantity, and document requirements. Ask the supplier to respond with material documentation, sampling path, QC release fields, packaging capability, and export document readiness.
For YUJI projects, use the RFQ checklist above and ask the team to confirm which specifications, certificates, tests, QC records, and packaging files are actually available and approved for your project. Final market claims remain the buyer’s responsibility. Contact YUJI through the channel listed on this site to begin the supplier screen and build a comparable RFQ response.