In almost every case, yes—you need a license to sell medical supplies, and usually more than one. The exact mix depends on what you sell, whether you manufacture or only distribute, whether you bill Medicare, and which states your customers sit in. A manufacturer pays an $11,423 FDA establishment fee for fiscal year 2026 and registers federally; a domestic-only distributor may skip that step entirely but still needs a license in every state where it ships. Getting the combination wrong can mean seized inventory, revoked billing privileges, and criminal exposure, so it’s worth mapping the whole picture before your first sale.
FDA Registration: Who Actually Has to Register
The federal piece trips up new sellers because it turns on your role, not on the fact that you handle devices. If your business manufactures, assembles, repackages, relabels, or imports medical devices, you must register your establishment with the FDA and list every device you market.1eCFR. 21 CFR Part 807 – Establishment Registration and Device Listing2Office of the Law Revision Counsel. 21 USC 360 – Registration of Producers of Drugs or Devices3U.S. Food and Drug Administration. href=”https://www.fda.gov/medical-devices/device-registration-and-listing/when-register-and-list” target=”_blank” rel=”noopener”>When to Register and List
The annual establishment registration fee for FY 2026 is $11,423.4Federal Register. Medical Device User Fee Rates for Fiscal Year 2026 Small businesses can apply for a waiver based on financial hardship.
If your business only distributes domestically manufactured devices without importing, repackaging, or relabeling them, you are not required to register with the FDA or pay the fee.5U.S. Food and Drug Administration. Who Must Register, List and Pay the Fee That exemption covers many retailers and wholesalers who buy from domestic manufacturers and resell the product untouched. The moment you import from a foreign manufacturer or put your own label on a product, you cross into the group that must register.
One boundary worth naming: FDA registration is separate from getting a specific device cleared for market. A Class II device generally needs a 510(k) clearance and a Class III device needs Premarket Approval before it can be legally sold, and those obligations sit with the manufacturer.6U.S. Food and Drug Administration. Classify Your Medical Device If you resell a device that was never properly cleared for its class, you can face enforcement action regardless of how clean your own licensing looks.
State Licenses You’ll Need
Every state licenses the sale of medical supplies, and the licensing agency varies: sometimes the Board of Pharmacy, sometimes the Department of Health, sometimes a dedicated medical device board.
What kind of license depends on your customer. Selling directly to patients usually requires a medical device retailer license. Supplying hospitals, clinics, or other resellers requires a wholesale distributor license. Retail permit fees generally run from around $100 to over $1,500 a year, and wholesale distributor licenses tend to fall between $200 and $500, though some states charge more. Common application requirements include corporate documents, proof of liability insurance, and fingerprint-based background checks for owners and key personnel.
The costly surprise is multi-state licensing. If you’re based in one state but ship to a customer in another, you generally need a license in the customer’s state too. A national operation can end up holding active licenses in dozens of states at once, each with its own renewal cycle, fee, and paperwork. CMS’s DMEPOS licensing guides are a workable starting point for identifying each state’s agency and requirements.7Centers for Medicare & Medicaid Services. DMEPOS CBP: Quality Standards, Accreditation, and Licensing
Durable Medical Equipment and Medicare Billing
Durable medical equipment (DME)—hospital beds, oxygen concentrators, wheelchairs, and other items designed for repeated use—carries an extra licensing layer. Most states require a specific DME license with standards for equipment safety, maintenance, and customer support that go beyond a general retail or wholesale permit.
If you plan to bill Medicare or Medicaid, you also have to enroll as a DMEPOS supplier with CMS. Enrollment has three main pieces: accreditation from a CMS-approved organization, enrollment through Medicare using Form CMS-855S, and a $50,000 surety bond for each National Provider Identifier your business maintains.8Centers for Medicare & Medicaid Services. Enroll as a DMEPOS Supplier The bond functions as CMS’s guaranteed recovery source if you violate federal billing rules.
Accreditation is not fast. The application review stage alone averages four to six months, and the full process typically runs longer. Approved suppliers are subject to periodic unannounced site visits, so the standards are an ongoing obligation.
Participation in national mail-order programs raises the bar again: you must hold applicable licenses in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, and American Samoa.7Centers for Medicare & Medicaid Services. DMEPOS CBP: Quality Standards, Accreditation, and Licensing
Pharmacies that sell only a small volume of DMEPOS may qualify for an exemption from the accreditation requirement, but the criteria are narrow: at least five years enrolled as a DMEPOS supplier, no final adverse action in that period, and DMEPOS billing (excluding drugs) under 5% of total pharmacy sales for the prior three years.9Centers for Medicare & Medicaid Services. Pharmacy Accreditation Exemption Statement Fact Sheet
Prescription-Only Devices
Some devices can only be sold on a practitioner’s order. Federal regulations require these products to be labeled “Rx only” or with equivalent language restricting sale to a licensed practitioner’s order.10eCFR. 21 CFR 801.109 – Prescription Devices If you sell them, you need a workable system for verifying a valid order before the product goes out the door.
For Medicare billing, the documentation rules are tighter. The treating practitioner must submit a written order to you before you can submit a claim, and that order has to include the beneficiary’s name or Medicare identifier, a description of the item, the practitioner’s name or NPI, the date, and the practitioner’s signature.11Centers for Medicare & Medicaid Services. DMEPOS Order and Face-to-Face Encounter Requirements Certain items also require documentation of a face-to-face encounter between the patient and the practitioner. You keep both the order and the supporting documentation on file and produce them to CMS on request.
Recordkeeping If You’re Only a Distributor
Being exempt from FDA registration doesn’t mean being free of federal recordkeeping. Distributors of medical devices must maintain complaint files documenting any incident reports they receive or generate, including communications alleging problems with a device’s identity, quality, safety, or performance, along with the distributor’s evaluation of each allegation.12eCFR. 21 CFR Part 803 – Medical Device Reporting
Complaint records must be kept for at least two years from the date the record was added, or the expected life of the device, whichever is longer, and they must be kept at your principal place of business. If you repackage or relabel a device, you also take on Unique Device Identification obligations, including assigning new device identifiers and maintaining records linking the old identifier to the new one.
The General Business Permits That Still Apply
The medical-specific licenses sit on top of the ordinary ones. Most cities and counties require a general business license to operate in their jurisdiction. If you sell taxable products, you need a sales tax permit from your state’s tax authority. Many states exempt prescribed medical devices from sales tax, but the exemption rules and definitions vary, so check your state’s specific rules rather than assuming.
Any business with employees needs a federal Employer Identification Number (EIN) from the IRS, and partnerships and corporations often need one even without employees.13Internal Revenue Service. Employer Identification Number
What Happens If You Sell Without the Right Licenses
Federal law makes it a prohibited act to sell adulterated or misbranded devices, or to fail to register an establishment when required.14Office of the Law Revision Counsel. 21 USC 333 – Penalties A first offense can carry up to one year of imprisonment as a misdemeanor, and violations involving intent to defraud or a prior conviction can be charged as felonies carrying up to three years. The FDA also has authority to seize non-compliant inventory and seek injunctions that shut operations down.
State penalties layer on top. Selling without a required state license can bring fines, revocation of any permits you do hold, and separate state criminal charges. For DMEPOS suppliers, CMS can revoke your Medicare billing privileges and demand repayment of claims, which is usually the most financially destructive outcome for a business that depends on Medicare reimbursement. The $50,000 surety bond exists for exactly that scenario.
Most compliance failures aren’t dramatic fraud cases. They’re businesses that started shipping into a new state without getting licensed there, or companies that began importing a product without updating their FDA registration. Those administrative slips trigger the same enforcement machinery as intentional violations, which is why a compliance calendar—renewal dates, registration windows, state-by-state license expirations—is worth building into your operations from day one.