Commercial Representation vs. Distributor Appointment

Commercial representatives and distributors both support market entry, but they perform fundamentally different roles. Clearly defining responsibilities helps avoid operational confusion and regulatory risk.

Commercial Representation Differs From Distribution

A commercial representative helps a manufacturer develop sales without necessarily becoming part of the product supply chain. The representative may identify prospects, arrange demonstrations, support quotations, coordinate customer discussions, and receive a commission or other sales-based fee.

Unless the agreement grants broader authority, the representative does not buy the device, take title, invoice the customer, collect payment, import the product, or hold inventory.

A Distributor Assumes a More Direct Commercial Role

A distributor appointment usually creates a more direct commercial role. The distributor may purchase products for resale, earn a margin rather than a commission, issue customer invoices, manage local inventory, and assume responsibility for parts of the order-to-cash process.

Depending on the operating model, the distributor may also act as Importer of Record or FDA Initial Importer, but those roles do not arise automatically merely because the company is called a distributor.

FDA defines the Initial Importer by the entity’s actual import and marketing activity, not by its commercial title.

Titles Do Not Determine Operational Responsibility

The distinction matters because manufacturers often use “representative,” “agent,” and “distributor” interchangeably even though the operational consequences are different.

A sales representative can generate demand while the manufacturer, a separate importer, or a Hybrid distribution partner controls inventory, customer invoicing, complaint intake, and regulatory records.

Conversely, a distributor may control the customer relationship and physical product flow even when the manufacturer retains certain pricing, branding, or regulatory decisions.

Define Each Party’s Authority and Responsibilities

The agreement should define who may bind the manufacturer, approve pricing, accept orders, invoice customers, collect funds, take title, arrange importation, hold inventory, process returns, receive complaints, and communicate during recalls or field actions.

Clear allocation prevents a sales appointment from unintentionally becoming a broader distribution arrangement.

Build a Flexible U.S. Commercial Structure

MDD Options can support a Hybrid structure in which the manufacturer retains commercial flexibility while MDD Options manages defined U.S. distribution, import, inventory, invoicing, complaint, and recall functions.

Where a separate sales representative or distributor is retained, MDD Options can also help map the parties’ responsibilities and identify operational gaps before launch.