| Product type and intended use |
Written confirmation that the product is an orthokeratology (Ortho-K) contact lens intended for overnight wear, with the available designs and fitting parameters. |
Compare the stated intended use, design options, and fitting information. Do not treat ordinary daily-wear lenses as interchangeable with overnight Ortho-K lenses. |
Confirm that the product’s intended use is permitted in the destination market and that supply is made through the legally required channels. |
| Regulatory status by destination |
Applicable market authorizations, registrations, declarations, certificates, and product-labeling documents for each target country or region. |
Check the issuing authority, product scope, certificate validity, and whether the documents cover the exact lens and manufacturing site being quoted. |
Requirements differ by market. Verify them with the relevant regulator or a qualified local regulatory professional before placing an order. |
| Quality management system |
Current quality-system certificate, its scope and expiry date, plus audit or corrective-action information where available. |
Check whether the certificate applies to the relevant manufacturing activities and site. ISO 13485 is a medical-device quality-management standard; certification alone does not establish market authorization. |
Validate certificates with the issuer or an accredited certification body, and confirm that the named legal entity matches the contracting party. |
| Lens specifications and standards |
Technical specifications such as material, oxygen permeability, base curve, diameter, power range, and measurement tolerances, supported by controlled product documentation. |
Compare like-for-like specifications and request clarification of units, test methods, and tolerances. ISO 18369 is a series of standards covering aspects of contact lenses and related products. |
Ensure specifications and test methods meet the requirements applicable in the destination market; do not rely on a catalogue description alone. |
| Clinical fitting and safety information |
Professional fitting guidance, patient instructions, contraindications, care and cleaning instructions, and adverse-event reporting procedures. |
Assess whether instructions are complete, consistent with the product’s authorized labeling, and available in the languages required for the intended market. |
Overnight lens wear carries risks, including eye infection. Ortho-K lenses require professional fitting and follow-up; procurement must not encourage unsupervised use. |
| Traceability and batch control |
Sample labels and packaging showing lot or batch identification, expiry or use-by information where applicable, and the manufacturer’s traceability process. |
Check that each shipment can be linked to production and release records, and ask how complaints, recalls, and field safety actions are handled. |
Agree in writing on record-retention, notification, and recall-cooperation responsibilities before commercial supply begins. |
| Testing and product release |
Representative inspection or test reports, release criteria, and documentation showing how nonconforming product is controlled. |
Review whether reports identify the tested product, batch, method, date, and acceptance criteria. Confirm that testing is relevant to the claims being made. |
Where independent testing is needed, agree on the laboratory, sampling plan, costs, and acceptance criteria before production. |
| Packaging and labeling |
Artwork or samples for primary packaging, instructions for use, storage conditions, and any market-specific labels. |
Compare readability, consistency with approved product information, and protection of the lenses during storage and transport. |
Confirm language, importer details, symbols, and other labeling elements required by the destination market before approving artwork. |
| Commercial terms and order planning |
Written quotation covering unit pricing, minimum order quantity, sample policy, production lead time, payment terms, and quotation validity. |
Compare total landed cost rather than unit price alone. Check whether quoted lead times and order quantities are confirmed for the required parameters and packaging. |
Specify currency, Incoterms® 2020 rule and named place, shipment schedule, inspection rights, and remedies for delays or nonconforming goods. |
| Export documents and shipment |
Proposed commercial invoice, packing list, transport documents, and any certificates or declarations required for the shipment. |
Check that product descriptions, quantities, tariff classifications, and shipper details are consistent across documents. |
Confirm import classification, duties, taxes, insurance, and any permits with the destination-country customs broker or relevant authority. |
| Supplier verification and communication |
Business registration details, manufacturing-site information, references where available, named quality and regulatory contacts, and a documented escalation route. |
Match the legal entity, factory, certificates, bank beneficiary, and contracting party. Treat unexplained mismatches or unverifiable claims as matters requiring resolution. |
Use written specifications and approved samples; document change-control requirements so material, design, site, or labeling changes are communicated before implementation. |
| Supplier scorecard |
Completed comparison records for regulatory readiness, quality evidence, technical fit, traceability, delivery capability, and total cost. |
Apply the same criteria to every candidate and record evidence, open questions, and risk ratings. Avoid selecting solely on the lowest quoted price. |
The table is a procurement checklist, not a certification or endorsement of any supplier. Confirm all product and regulatory details independently before purchase. |