Distribution agreements are a core part of bringing medical devices to market, but they involve more than commercial terms alone. Regulatory responsibilities, product claims, quality controls and post-market obligations can all affect how the relationship should be structured.
Start with the regulatory framework
The parties should first identify the regulatory status of the relevant products and clarify which entity will be responsible for registrations, licences, importation and local regulatory communications.
Key contractual issues
Territory and exclusivity
The agreement should clearly define the territory, sales channels and whether the distributor is appointed on an exclusive or non-exclusive basis.
Regulatory responsibilities
Responsibilities for product registration, renewals, labelling, promotional materials and regulator-facing communications should be expressly allocated.
Quality, complaints and recalls
The contract should set out how the parties will manage adverse events, customer complaints, corrective actions, product returns and recalls.
Commercial terms and performance
Pricing, forecasts, minimum purchase obligations, payment terms and performance expectations should align with the intended commercial model.
Termination and transition
Termination provisions should address remaining inventory, regulatory records, customer communications and any transition support required after the relationship ends.
Key takeaway: A strong distribution agreement should connect commercial objectives with the regulatory reality of the product and market.
Practical checklist
- Confirm product classification and registration responsibilities.
- Define ownership and use of trademarks and marketing materials.
- Allocate liability for regulatory non-compliance and product issues.
- Set clear procedures for complaints, recalls and reporting.
- Plan for expiry or termination before the agreement is signed.
