How to Get a Medical Supply License: Which Licenses Apply

Short answer: in the United States there is no single “medical supply license.” What you need depends on what you sell, whether you import or relabel it, and whether you bill Medicare. Four separate things get called a “medical supply license”: a state license where your state requires one, a state resale or seller’s permit, FDA establishment registration (only for certain activities), and Medicare DMEPOS supplier enrollment. This page sorts them by seller type. It is general information, not legal or medical advice.

Already know which gate you are on? Go straight to the DME license guide, how to get a wholesale license, resale certificate vs seller’s permit, or how to start a DME business. This guide is the map that tells you which of those apply.

Do you need a license to sell medical supplies?

It depends on the item, the state and the payer. The federal rule for Medicare equipment suppliers says that if a State requires licensure to furnish certain items or services, the supplier must be licensed to provide them (42 CFR 424.57(c)(1)(ii)). The rule does not list which states require a license or for which items; that is set by each state. Selling to Medicare beneficiaries adds federal requirements on top (see below). A seller that never bills Medicare faces the state and FDA questions only.

Which licenses and registrations apply to which kind of seller

If you are…	FDA establishment registration	Who to ask next
A wholesale distributor that is not a manufacturer or importer	FDA’s table lists no registration, no device listing and no fee	Your state tax agency (resale) and any state licensing board for your products
A domestic distributor that does not import devices	Exempt from registration, listing and fee	Same as above
An initial importer (you further the marketing of a device from a foreign manufacturer without repackaging or relabeling it)	Must register and pay the fee; does not list devices; needs a U.S. physical address staffed by people responsible for compliance	FDA Registration and Listing staff
A relabeler or repackager	Must register, list and pay the fee	FDA Registration and Listing staff
A refurbisher or remarketer of used devices already in U.S. commercial distribution	Not required to register, list or pay the fee	Your state agencies
A supplier that wants to bill Medicare for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)	Depends on the activities above	The Medicare enrollment contractor and an approved accreditation organization

Source for the FDA column: FDA, “Who Must Register, List and Pay the Fee,” checked 2026-11-01. The FDA page does not describe retail shops, so this table makes no claim about them. FDA registration is an establishment record, not an approval of your products.

What you need

• A clear list of what you will sell and to whom: patients, clinics, labs, or Medicare beneficiaries.
• A statement of your role for each product: wholesale only, importer, relabeler or repackager, or reseller of used goods.
• Business identity documents you already hold (entity formation papers, EIN, business address). State and Medicare forms ask for documents like these; each agency publishes its own list.
• For Medicare DMEPOS enrollment only: an NPI, comprehensive liability insurance of at least $300,000, a surety bond, and accreditation (details below).

Steps

1. Write down your seller type from the table above.
2. Ask your state’s licensing or health agency, in writing, whether the products you will sell require a state license. Keep the reply.
3. Ask your state tax agency how resale or seller’s permits work for your sales. The next section explains how this differs from a “medical supply license.”
4. If you import, relabel or repackage devices, check your activity against FDA’s registration table and contact the FDA Registration and Listing staff with questions.
5. If you will bill Medicare for DMEPOS, work through the supplier standards, accreditation and enrollment in the DME business guide.
6. Calendar renewals and change reports for every license, permit, bond, policy and accreditation you end up holding.

Medical supply business license vs reseller license

They are different documents from different agencies. A reseller license (also called a resale certificate or seller’s permit, depending on the state) is a sales-tax matter handled by each state’s tax agency. A state medical supply or DME license, where a state requires one, is a health-sector licensing matter. Having one does not satisfy the other. This page does not state any state’s tax rules; see how to get a wholesale license and resale certificate vs seller’s permit for that side.

How to get a reseller license

Reseller licensing is run by your state’s tax agency, so the form, name and requirements vary by state. Ask the agency directly what it requires and whether it accepts certificates from other states. The wholesale license guide linked above walks through the general sequence of EIN, state registration and supplier accounts.

FDA registration: who must and who is exempt

Owners or operators of establishments involved in the production and distribution of medical devices intended for U.S. use register with FDA each year (establishment registration, 21 CFR Part 807), and FDA collects an annual establishment registration fee. FDA’s “Who Must Register” table, checked 2026-11-01, marks these as not required to register, list or pay: a wholesale distributor that is not a manufacturer or importer; a domestic distributor that does not import devices; import agents and brokers who do not take first possession of an imported device; and refurbishers or remarketers of used devices already in U.S. commercial distribution. It marks relabelers and repackagers as required to register, list and pay, and initial importers as required to register and pay (without listing). The current fee amount is on FDA’s registration page.

Medicare DMEPOS supplier requirements

These apply only if you enroll in Medicare as a DMEPOS supplier. They come from 42 CFR 424.57, checked 2026-11-01 on Cornell LII’s copy of the CFR:

• State licensure: where a State requires licensure for certain items or services, the supplier must be licensed to provide them, (c)(1)(ii). Oxygen must be obtained from a State-licensed oxygen supplier in States that require oxygen licensure, (c)(27).
• Insurance: a comprehensive liability policy of at least $300,000 covering the place of business and all customers and employees, (c)(10). Failure to maintain required insurance at all times results in revocation of billing privileges.
• Surety bond: the supplier must meet the bond requirements in paragraph (d), (c)(26).
• Accreditation: suppliers must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare, for the specific products and services listed, (c)(22). Accredited suppliers must be surveyed and reaccredited at least once every 12 months, (c)(24).
• NPI: the bond requirements apply for each assigned NPI for which the supplier seeks billing privileges, (d)(1).

See the DMEPOS supplier standards and DMEPOS accreditation for the full list. Medical gases have their own federal and state layers; check the federal and state rules for the specific gas.

What can go wrong

• Treating a resale certificate as a medical license. They answer different questions for different agencies.
• Assuming FDA registration is approval. It is an establishment record.
• Missing the importer or relabeler trigger. Importing, or changing the container, wrapper or labeling, puts you in a different FDA row than the distributor.
• Applying Medicare rules to a non-Medicare business, or the reverse. The 42 CFR 424.57 standards bind Medicare DMEPOS enrollees.
• Letting insurance lapse. For Medicare DMEPOS suppliers, failure to maintain the required insurance results in revocation of billing privileges.

When to get professional help

Ask a health-care or business attorney, or the agencies named above, when you are unsure whether you are an importer, relabeler or repackager; when your products fall into state-regulated categories such as oxygen; when you plan to sell in several states; or before you submit a Medicare enrollment application.

FAQ

How do I get a medical supply license?

There is no single license. Identify your seller type, ask your state whether your products require a state license, handle resale or seller’s permits with your state tax agency, check FDA’s registration table for your activity, and, if you bill Medicare, complete supplier standards, accreditation and enrollment.

Do you need a license to sell medical supplies?

Possibly. Federal Medicare rules require a state license where the state requires one for the item or service (42 CFR 424.57(c)(1)(ii)); which items and states that covers is set by each state.

Does a wholesale distributor have to register with FDA?

FDA’s table, checked 2026-11-01, lists a wholesale distributor that is not a manufacturer or importer as not required to register, list or pay the fee.

Is a reseller license the same as a medical supply license?

No. A reseller license is a sales-tax document from a state tax agency; a medical supply or DME license, where required, is a state health-sector license.

Sources

• FDA, Who Must Register, List and Pay the Fee, checked 2026-11-01.
• FDA, Device Registration and Listing, checked 2026-11-01.
• 42 CFR 424.57, Special payment rules for items furnished by DMEPOS suppliers (Cornell LII), checked 2026-11-01.