Written and maintained by CASRAI Editorial Board
Published · Last updated
On this page
Short answer: A reseller agreement is a contract in which a supplier or manufacturer lets a business buy its products and resell them to its own customers. For medical and laboratory supplies, the commercial terms are only half the picture: what the reseller does with the product (resell it as received, relabel it, repackage it, import it) decides which FDA obligations attach to the reseller, and the agreement should say who holds which records. This page explains the concept for lab and clinic staff and supply buyers. It is general information, not a template and not legal advice.
Definition and scope
In a reseller arrangement, the reseller buys goods and sells them on in its own name. That separates it from an affiliate agreement, where the partner refers buyers and the supplier sells, and from a general channel partner relationship, which can include referral, resale or service roles. Reseller agreements commonly cover the products and territory covered, whether resale is exclusive, how customers and branding are handled, ordering and payment terms, warranty and returns, confidentiality, and how the relationship ends. These are the clauses typically discussed in general contract guidance; the specific terms are negotiated between the parties and vary from deal to deal.
Reseller agreement vs distributor agreement vs affiliate agreement
Distributor reseller agreement
The words “reseller” and “distributor” are often used loosely in commerce, so read what the document actually says about who buys, who takes possession and who sells to the end customer. Exclusivity and territory in a distribution deal are covered in the distributor agreement guide, and the FDA-specific clauses for devices are in the medical device distribution agreement guide. This page does not repeat them.
What matters in practice
- Reseller: buys the product and resells it. The agreement is mainly about purchase terms and what the reseller may say and do with the product.
- Affiliate: refers buyers to the supplier. See the affiliate agreement guide.
- Private-label or white-label arrangement: the product is sold under the seller’s own name, which can change the regulatory role. See what white labeling is.
Reseller agreement template: what a template cannot tell you
A generic template covers the commercial clauses above. It cannot tell you what role your business holds under FDA rules, because that depends on what you do with the device, not on the heading of the contract. Before using any template for medical or lab supplies, decide first whether you will resell products exactly as received, put your own labeling on them, repackage them, or import them, because the answer changes what the agreement needs to say.
Where the FDA role matters for medical supplies
The FDA’s page “Who Must Register, List and Pay the Fee” (checked 2026-11-03) draws these lines for device establishments:
| What the business does | Registration, listing and fee under the FDA chart |
|---|---|
| Wholesale distributor that is not a manufacturer or importer | Not required to register, list or pay the fee |
| Domestic distributor that does not import devices | Not required to register, list or pay the fee |
| Repackager (repackages devices made by a manufacturer into different containers) | Must register, list and pay the fee |
| Relabeler (changes the content of the labeling supplied by the original manufacturer, for distribution under its own name) | Must register, list and pay the fee |
| Initial importer (furthers the marketing of a device from a foreign manufacturer) | Must register and pay the fee |
| Import agent or broker that does not take first possession | No registration, listing or fee requirement |
Under 21 CFR 807.3(t), a wholesale distributor is any person other than the manufacturer or the initial importer who distributes a device from the original place of manufacture to the person who makes the final delivery. The FDA also notes that a relabeler does not include an establishment that does not change the original labeling but merely adds its own name. For a reseller agreement, the practical consequence is that a clause allowing the reseller to relabel, repackage or import should be read as a change of the reseller’s regulatory position, not just a branding permission.
Authorized reseller agreement: documents to ask for and questions to answer
“Authorized” is a claim a manufacturer makes about a reseller, so it is worth asking for it in writing. This checklist is an editorial aid built from the points above; it is not a legal requirement and is not exhaustive.
- Does the agreement or an authorization letter name the products and the territory the reseller may sell in?
- Will the reseller resell as received, or is relabeling, repackaging or importing contemplated? If so, which party carries the FDA registration for that activity?
- Which party receives product complaints and keeps the complaint file (see the next section)?
- If a seller states that it is an authorized reseller, can the manufacturer confirm it? Registration with the FDA is not an approval or endorsement; 21 CFR 807.39 says registration does not denote approval of the establishment or its products.
Records a reseller keeps
Under 21 CFR 803.18(d), a device distributor must establish and maintain device complaint records. The records must contain any incident information, including written, electronic or oral communication received or generated, that alleges deficiencies related to the identity (for example, labeling), quality, durability, reliability, safety, effectiveness or performance of a device, along with information about the distributor’s evaluation of the allegations, if any. They must be clearly identified as device incident records and filed by device name, and kept for 2 years from the date the record was included in the file or for a period equivalent to the expected life of the device, whichever is greater, even if the device is no longer distributed. A reseller agreement should therefore say how a customer complaint reaches the reseller, how it is passed to the manufacturer, and who keeps the file.
Common mistakes
- Treating a template as sufficient for a regulated product without deciding what the reseller will do with the device.
- Assuming that a reseller that adds its own name must register as a relabeler. The FDA states that merely adding a name to unchanged labeling does not make an establishment a relabeler; changing the labeling content does.
- Reading FDA registration as manufacturer approval of the reseller or its products.
- Leaving complaint handling unassigned, so that incident information received by the reseller never reaches the right file.
Frequently asked questions
What is meant by “reseller agreement”?
It is a contract under which a business buys a supplier’s products and resells them to its own customers, setting out the products, territory, purchase terms and responsibilities of each side.
How does it apply to medical supply buyers and sellers?
For sellers, the agreement should match the reseller’s actual FDA role: a wholesale distributor that does not manufacture or import is not required to register, while a relabeler, repackager or initial importer is. For buyers, it is the document that shows who the seller sources from and who is responsible for complaints. For general onboarding steps, see how to become a medical supply reseller.
What are common examples and common mistakes?
Examples include a lab consumables reseller buying from a manufacturer and selling to clinics as received, or a seller that applies its own labeling to a product. The mistakes are listed above: using a template without deciding the regulatory role, misreading registration as approval, and leaving complaint records unassigned.
Sources
- U.S. Food and Drug Administration, “Who Must Register, List and Pay the Fee”: https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee (checked 2026-11-03).
- 21 CFR 807.3, definitions including wholesale distributor: https://www.law.cornell.edu/cfr/text/21/807.3 (checked 2026-11-03).
- 21 CFR 807.39, misbranding by reference to registration: https://www.law.cornell.edu/cfr/text/21/807.39 (checked 2026-11-03).
- 21 CFR 803.18, distributor device complaint records: https://www.law.cornell.edu/cfr/text/21/803.18 (checked 2026-11-03).
