| Intended use and claims | Check whether the product is marketed as a general nasal-opening aid or with medical claims, such as relief of nasal congestion. | Product label, instructions for use, website claims, and promotional materials should describe the same intended purpose. | Regulatory status depends on intended purpose and market. Do not assume that one classification applies to every nasal strip. |
| FDA status | Ask the supplier to identify the applicable U.S. regulatory pathway and provide product-specific supporting records. | Check relevant FDA database records where applicable. Confirm that the manufacturer, device description, and marketed product match the supplied documentation. | Verify product-specific status FDA establishment registration or device listing does not, by itself, mean FDA approval or clearance. Do not advertise a strip as “FDA cleared” without evidence of the applicable clearance. |
| EU MDR 2017/745 classification | Request the manufacturer’s documented classification rationale based on intended purpose and applicable MDR rules. | For a non-invasive medical device, Rule 1 may be relevant; the final classification must be confirmed against the device’s intended purpose and design. | Some Class I devices may be self-declared by the manufacturer. Class I sterile, measuring, or reusable surgical-instrument cases have additional notified-body involvement. Confirm the actual route rather than assuming it. |
| EU Declaration of Conformity and CE marking | For products placed on the EU market as medical devices, check the EU Declaration of Conformity and the basis for CE marking. | Verify that the declaration identifies the manufacturer, device or product family, applicable legislation, and relevant classification. | CE marking is not a generic quality certificate. Check that the documentation matches the product and its intended purpose under MDR 2017/745. |
| Skin-contact materials and adhesive | Review the backing, adhesive, and any materials that contact the skin; ask about known allergens and removal instructions. | Request material specifications, supplier declarations, and risk-management or biocompatibility rationale appropriate to the contact type and duration. | Evidence should be relevant to the finished product and its intended contact. Avoid treating a raw-material certificate as proof of finished-device compliance. |
| Size and fit | Compare strip dimensions, shape, flexibility, and fit guidance with the intended user population. | Request a size chart, clear application instructions, and samples for fit and adhesion evaluation across representative users. | There is no single universal strip size or fit standard for all users. Claims about size suitability should be supported by product-specific information. |
| Adhesion and removal performance | Evaluate secure wear during the stated use period and comfortable removal from clean, dry skin. | Ask for test methods and results covering adhesion, wear conditions, removal, and any defined performance limits. | Use performance data that reflects the final strip and its instructions. Avoid unsupported “all-night” or similar duration claims. |
| Safety information and labeling | Check directions, warnings, contraindications, storage conditions, and the intended user group. | Labeling should explain correct placement and removal and include relevant cautions, such as not applying to irritated or damaged skin where applicable. | Requirements vary by destination market and product status. Provide required local-language information where applicable. |
| Traceability and quality controls | Review lot or batch identification, complaint handling, change control, and recall procedures. | Request a sample label and documentation showing how supplied lots can be traced to production and release records. | Confirm the controls required for the product’s regulatory status and each target market; do not rely on a certificate without checking its scope and validity. |
| Packaging and shelf life | Check pouch or pack integrity, storage conditions, and any stated expiry or shelf-life period. | Request packaging specifications and supporting shelf-life or stability evidence for the marketed configuration. | Expiry dates and storage claims should be supported by product-specific evidence and consistent with the label. |
| Import and market access | Confirm importer, responsible-person, registration, language, and customs requirements for each destination country. | Use a market-by-market checklist and verify requirements with the relevant authority or a qualified local regulatory professional. | FDA and EU MDR requirements do not automatically satisfy every country’s rules. Import obligations can differ by market and product claims. |