GuidelinesGMP2026.10.08
Medical-Device OEM Quality Agreements: Agree Change Notices and Data Access First
Price and delivery terms do not establish an audit or complaint-investigation process. Define evidence, approvals, changes and post-market cooperation between the commissioning company and manufacturer.
Supply terms and quality arrangements answer different questions
A contract may define price, volume and delivery but leave regulatory evidence ownership unresolved. A quality agreement identifies who creates, reviews and approves evidence across design, production, inspection, release and post-market work. Workable content matters more than the document’s title.
Outsourcing does not transfer every statutory responsibility by contract. Korean KGMP addresses commissioning-manufacturer arrangements, so confirm sites and outsourced activities. Review business roles alongside the manufacturer licensing guide.
Allocate activities, not a blanket responsibility
“The manufacturer is responsible for quality” does not decide who approves a revised drawing or disposes of nonconforming stock. Break down actual development, purchasing, production and quality activities. Identify both performer and approver where different, and maintain contact routes after personnel changes.
| Activity | Agreement topics |
|---|---|
| Design/specifications | Approved baseline, change authority, implementation timing |
| Purchasing/outsourcing | Critical suppliers, subcontracting, change notification |
| Inspection/release | Criteria, records, nonconformity disposition, release approval |
| Validation | Planning, execution, approval, reassessment |
| Complaints/recall support | Intake, investigation, traceability, decision support |
These are discussion topics, not universal contract wording. Secure access, personnel and information flows rather than assigning duties that a party cannot perform.
Define records by list, format and availability
“We will provide required documents” can leave every request open to renegotiation. List process maps, test source data, manufacturing and inspection records, equipment/process validation, materials/components and changes. Separate routine shipment evidence from records needed during review or investigations, and specify access methods.
Include language, format, approval status and version so documents are usable. For trade secrets, consider confidentiality and controlled viewing or submission. Identify before contracting where a summary certificate cannot adequately explain safety or quality.
Make changes subject to impact assessment
Materials, critical components, processes, sites, methods and subcontractors can affect authorizations and test evidence. Define changes requiring prior notice or approval, urgent-change handling and decisions on holding shipment or re-verification. The parties should agree notification periods suited to risk and supply arrangements.
Design notices to include before/after comparison, reason, affected products/lots, implementation date and verification evidence or plans. “Replaced with an equivalent” should not close the issue by itself. Use the regulatory-change guide to separate internal approval from regulatory assessment.
Link complaint and nonconformity records on both sides
A Korean complaint without product identification, lot, circumstances and sample condition may delay investigation. A production defect not communicated to the Korean business may prevent evaluation of already shipped devices. Define two-way notification triggers and urgent contacts.
Allocate investigation, interim action, affected-lot review, recurrence prevention and effectiveness checks. Commercial compensation and safety actions may proceed at different speeds; design the procedure so quality decisions are not stalled by commercial disputes.
Check that the signed agreement works in practice
Review supplier evaluations, changes, delivery nonconformities and record-access history to confirm that the process operates. Include certificate scope and validity, actual sites and process coverage for the product in the review plan.
Also define record retention and access, unresolved complaints/actions and traceability for past production after termination. Bring process maps, site roles, supply terms and existing agreements to an OEM quality-system review to find gaps in actual information and approval flows.
Sources checked: 2026-09-28. The tables and preparation steps are practical suggestions; confirm the legal submission scope and applicable standards for the particular product.
Frequently asked questions
- Q. Does the OEM’s ISO 13485 certificate replace a quality agreement?
- It is useful evaluation evidence, but does not allocate product-specific responsibilities, data access or change notices. Controls must fit the outsourced scope and applicable requirements.
- Q. What if records are confidential?
- Agree confidentiality and necessary regulatory or audit access before contracting. Specify whether summaries suffice and whether controlled viewing or submission can provide the required evidence.
- Q. Must all suppliers receive the same controls?
- Choose evaluation and control levels according to quality impact, process characteristics and verifiability. Different supplier types may need different evidence and change controls.