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Documents & Compliance Support for Nasal Strips & Mouth Tape
Document gaps are where launches stall — at customs, at marketplace review, or at a retailer’s compliance desk. Here’s what we hold, what you or your importer holds, and how the list is confirmed for your market.
What the manufacturing side provides
| Document | What it covers | Availability |
|---|---|---|
| ISO 13485 certificate | Quality management system for medical devices | On request |
| FDA registration | US facility registration | On request |
| CE documentation | EU conformity documentation | On request |
| ISO 10993 biocompatibility | Skin-contact material safety documentation | On request |
| Material declarations | REACH, RoHS, SVHC, PFAS statement | On request |
| Per-product test reports | Product-specific testing | On request |
| Product & packaging specifications | For listing, internal evaluation, quote comparison | Prepared per product version |
| SDS / TDS, adhesive information | Professional procurement, customs, compliance | Confirmed per product version and market |
Who registers what
In most Western markets (US, EU, UK, CA, AU), nasal strips are a Class I medical device. The registration or listing is usually held by you or your importer — not the factory. Our role is the manufacturing side: quality system, biocompatibility, test reports and material files that your registration, customs clearance and marketplace listing process will ask for. Knowing this split early saves weeks at launch.
How we confirm your document list
- You tell us the target market and channel — country, marketplace/retail/DTC.
- We map manufacturing-side documents against what that market typically requests.
- Gaps are flagged before quoting — including anything that needs confirmation for your specific product version.
Frequently asked questions
Why don’t you publish your certificates on the website?
Because certificate versions renew periodically. Publishing a fixed PDF invites two failure modes: an outdated file circulating, or a claim that no longer matches the current version. We send current documents on request — under NDA where appropriate — so what you file is what’s actually valid.
Which documents will my market ask for?
It differs by market and channel (customs, marketplace, retailer). In most Western markets nasal strips are a Class I device with registration held by the brand/importer; typical manufacturing-side items are the quality-system certificate, biocompatibility documentation, test reports and material declarations. We confirm the exact list for your target market before quoting.
Can you help with Amazon listing documentation?
We provide the manufacturing-side documents marketplaces typically request. Marketplace policies change and differ by category and country, so we work from your marketplace’s current checklist rather than promising blanket acceptance.
Get the document list for your market
Tell us your target market and sales channel — we’ll map the manufacturing-side documents and flag any gaps before you commit to an order.