Medical Device Distribution Agreement

Manufacturer: [Company Name] · Distributor: [Company Name] · Device(s): [Description] · Date: [Date]

1. Appointment

Manufacturer appoints Distributor as [exclusive/non-exclusive] distributor of the device(s) described above within [Territory].

2. Regulatory Compliance

Manufacturer represents that the device(s) hold all required regulatory clearances/approvals (e.g. FDA 510(k)/PMA, CE marking) for sale in the Territory. Distributor will not modify, relabel, or misrepresent the device(s) in any way that would affect this regulatory status.

3. Pricing and Orders

Distributor purchases at [Wholesale price/discount schedule], subject to minimum order quantities of [Amount].

4. Adverse Event Reporting

Distributor will promptly forward to Manufacturer any complaints, adverse events, or malfunction reports it receives regarding the device(s), consistent with applicable medical device reporting requirements.

5. Recalls

Distributor will cooperate fully with Manufacturer in the event of a product recall, including providing distribution records to trace affected units.

6. Insurance

Distributor maintains product liability insurance of at least [Amount].

7. Term and Termination

This Agreement runs for [Term] and may be terminated by either party with [Notice Period] notice, or immediately if the device(s) lose required regulatory clearance.

Manufacturer: ______________________ Date: ____________ Distributor: ______________________ Date: ____________

*This document is provided for informational and educational purposes only and does not constitute legal advice. Medical device distribution carries real regulatory reporting obligations (Section 4) that go beyond a typical distribution agreement — both parties should understand their specific adverse-event and recall responsibilities under applicable medical device law before signing.*