What kind of agreements are crucial when working with distributors?

Manufacturers should have comprehensive quality agreements or contracts with distributors that explicitly define roles, responsibilities, reporting requirements, and compliance expectations, covering aspects like adverse event reporting, complaint handling, and product traceability.

How does the sales model affect post-market surveillance?

Regardless of the sales model, manufacturers are responsible for post-market surveillance. When using distributors, manufacturers must ensure they have mechanisms to collect post-market data, complaints, and adverse event reports from all sales channels.

Are there cybersecurity implications for different sales models?

Yes, cybersecurity considerations apply to both direct and distributed sales. For distributed models, manufacturers must ensure distributors handle device information and connectivity securely, adhering to recognized security standards like ISO/IEC 27001 or specific cybersecurity guidance from regulators like the FDA pre-market submission requirements for cybersecurity.

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CommercializationHospital Buyer & Reimbursement

Distributor vs Direct Sales

Choice between selling through third-party distributors or hiring a direct salesforce.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

A direct salesforce is employed and trained by the manufacturer. Distributors are independent firms that carry the product alongside others. Hybrid models - direct in core geographies, distributors in long tail or OUS - are common. Distributors offer faster market access and local relationships, while direct sales give more control and margin. Many companies use distributors in smaller markets and sell directly in large ones. Contracts should cover exclusivity, complaint handling, vigilance duties and termination rights.

What the regulation says

From a regulatory standpoint, the manufacturer (or their authorized representative in some regions, such as the EU under the EU MDR) retains ultimate responsibility for product quality, safety, and regulatory compliance, regardless of the sales model. For instance, the FDA expects manufacturers to ensure that medical devices distributed in the U.S. comply with applicable regulations, as outlined in 21 CFR Part 820, even if sales are facilitated through third parties. Similarly, the EU MDR (Regulation (EU) 2017/745) clearly defines the responsibilities of manufacturers, authorized representatives, importers, and distributors, emphasizing that manufacturers are accountable for placing compliant devices on the market.

What this means in practice

Direct gives control of brand, KOL, and pricing; costs more upfront. Distributors give faster geographic reach with weaker control. Most MedTech companies start hybrid and convert to direct as scale justifies.

Examples

A manufacturer directly employs a sales team to manage key hospital accounts in North America, maintaining tight control over product messaging and service delivery.
A MedTech company partners with an independent distributor network in Europe to leverage their established market access and local knowledge for wider geographic reach.
A manufacturer uses a hybrid approach, with a direct salesforce for high-volume urban markets and distributors for rural or international markets to optimize resource allocation and market penetration.

Common pitfalls

•Manufacturers often incorrectly assume that distributors completely absorb regulatory responsibilities, leading to gaps in compliance oversight.
•Failing to establish clear contractual agreements with distributors regarding regulatory responsibilities, post-market surveillance, and incident reporting can lead to significant issues.
•Not adequately training distributors on product use, regulatory requirements, and quality system procedures is a common mistake.
•Assuming that direct sales models eliminate all regulatory risks associated with external sales channels overlooks internal training and oversight needs.
•Neglecting to monitor distributor performance and adherence to quality agreements can result in non-compliance and reputational damage.

Frequently asked questions

No, a manufacturer's ultimate regulatory responsibility for the device remains, even when using distributors. Distributors have their own set of responsibilities, but they do not absolve the manufacturer of theirs.

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Sources

4 sources

Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 2Regulator guidance and consensus· 1Tier 4Trade press and expert commentary· 3

Link health: 4 verified· last checked 2026-06-20· added official documents checked 2026-11-01

AdvaMed·2AHRMM·1U.S. Food and Drug Administration·1

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Learn in 60 seconds

Choice between selling through third-party distributors or hiring a direct salesforce.

·Direct gives control of brand, KOL, and pricing; costs more upfront.
·Distributors give faster geographic reach with weaker control.
·Most MedTech companies start hybrid and convert to direct as scale justifies.

Remember this

Watch out: Manufacturers often incorrectly assume that distributors completely absorb regulatory responsibilities, leading to gaps in compliance oversight.

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