| Product Classification | Confirm intended use, patient contact, invasiveness, sterility status, and applicable risk class before requesting quotations. | Product specification, intended-use statement, risk classification rationale, and regulatory pathway. | Create a country-by-country compliance matrix rather than using one approval assumption for every market. |
| Quality Management System | A medical-device quality system should address design controls, purchasing, production, traceability, complaints, corrective actions, and change control. | Current ISO 13485 certificate, certification scope, issuing body, audit status, and certificate validity. | Verify the certificate directly through the issuing certification body where possible. |
| Risk Management | Risks should be identified and controlled throughout the product life cycle, including manufacturing, transport, use, and disposal. | Risk-management file aligned with ISO 14971, hazard analysis, residual-risk evaluation, and benefit-risk documentation. | Request objective evidence that risk controls are linked to verification and validation results. |
| Biocompatibility | Materials and patient-contact duration determine the applicable biological evaluation requirements. | Biological evaluation report and applicable testing based on the ISO 10993 series, including cytotoxicity, sensitization, or irritation when relevant. | Check that testing covers the final device, finished materials, processing aids, and packaging-related residues. |
| Sterilization Method | Common validated methods include ethylene oxide, radiation, and moist heat; the method must suit the device materials and packaging. | Sterilization validation, routine-cycle records, dose or process specifications, and residual testing where applicable. | For ethylene oxide products, review residual limits and aeration controls; for radiation products, review dose mapping and dose range. |
| Sterile Barrier and Packaging | Packaging must maintain sterility and protect the device during handling, transport, and storage until the point of use. | Packaging validation, seal-strength results, integrity testing, aging studies, and transport-simulation reports. | Confirm packaging performance after accelerated and real-time aging where shelf-life claims require it. |
| Shelf Life and Storage | Shelf life must be supported by stability and packaging evidence; storage limits should address temperature, humidity, light, and physical damage. | Expiry-date rationale, aging protocol, storage specification, and product labeling. | Select a supplier whose stated shelf life covers the complete purchasing, shipping, customs, and distribution cycle. |
| Regulatory Documentation | Documentation requirements vary by destination, device class, and intended use. A quality certificate alone does not equal market authorization. | Declaration of conformity, technical documentation index, applicable test reports, registration records, and labeling samples. | Confirm whether the importer, authorized representative, or local registration holder has additional obligations. |
| Product Standards | Use internationally recognized standards where applicable, such as ISO 10993 for biological evaluation, ISO 14971 for risk management, and relevant device-specific standards. | Standards list, test-plan cross-reference, laboratory reports, and latest applicable revision assessment. | Avoid accepting a generic compliance statement without identifying the exact standard and test scope. |
| Supplier Manufacturing Capability | Evaluate cleanroom controls, equipment qualification, process validation, operator training, inspection capacity, and production continuity. | Facility questionnaire, process-flow chart, validation summary, training records, and recent audit findings. | Use a documented supplier audit or qualified independent audit for critical or high-volume products. |
| Incoming and Final Inspection | Inspection should cover dimensions, appearance, functionality, packaging integrity, labeling, and sterility-related release requirements. | Inspection plans, acceptance criteria, sampling method, batch-release records, and certificate of analysis when applicable. | Agree on measurable acceptance criteria before approving the first production order. |
| Lot Traceability | Each shipment should be traceable to production date, raw materials, sterilization cycle, inspection results, and packaging configuration. | Lot number format, batch records, sterilization release records, and traceability procedure. | Require consistent lot identification on unit packaging, cartons, shipping documents, and electronic records. |
| Change Control | Changes to materials, sterilization, manufacturing location, packaging, labeling, or critical processes may affect regulatory status and performance. | Written change-notification procedure, change assessment, validation plan, and customer notification terms. | Include advance notification and approval requirements for changes that could affect fit, function, safety, or compliance. |
| Order Quantity and Lead Time | Separate standard production lead time from tooling, artwork approval, validation, sterilization, and export-document preparation time. | Capacity statement, production schedule, minimum order quantity, and historical on-time-delivery data. | Use forecast sharing and safety stock for products with long validation or replenishment cycles. |
| Incoterms and Landed Cost | Compare product price, packaging, inland transport, freight, insurance, duties, taxes, customs clearance, and destination delivery under the same Incoterms® 2020 basis. | Formal quotation, Incoterm location, freight assumptions, harmonized tariff classification, and duty estimate. | Evaluate total landed cost instead of comparing unit prices alone. |
| Transport and Shipping Mode | Air freight generally supports shorter transit times, while ocean freight usually offers lower cost for larger, non-urgent shipments. | Transit-time estimate, route plan, carton dimensions, gross weight, loading plan, and carrier booking procedure. | Select the mode based on expiry risk, inventory cost, urgency, and product-volume requirements. |
| Customs and Import Documents | Typical documents include commercial invoice, packing list, transport document, certificate of origin when required, and regulatory records. | Document checklist, sample shipping set, product description, tariff code, and importer-of-record information. | Pre-clear documents with the customs broker and verify that product descriptions match the physical shipment. |
| Labeling and Language | Labels commonly need product identification, lot number, expiry date, sterile status, storage conditions, manufacturer details, and required symbols. | Artwork approval record, labeling review, symbol reference, translation validation, and destination-market checklist. | Approve final artwork only after regulatory and language review for each target market. |
| Complaint and Recall Readiness | The supplier should maintain procedures for complaint intake, investigation, adverse-event escalation, field action, and recall effectiveness checks. | Complaint procedure, response-time commitment, recall plan, contact list, and corrective-action records with confidential details removed. | Define escalation contacts and response deadlines in the quality or supply agreement. |
| Commercial and Quality Agreement | The agreement should define specifications, acceptance criteria, audit rights, change control, delivery terms, nonconformance handling, and document retention. | Signed supply agreement, quality agreement, technical specification, and approved sample or master reference. | Score suppliers using weighted criteria: compliance, quality, supply continuity, logistics, service, and total cost. |
