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Selling on Amazon · US

Can I sell medical devices on Amazon, and what do I need?

In one line

Yes, but Amazon has to approve you for medical devices before you list. The device must already be FDA registered and listed, and, where the device type needs one, cleared through the FDA's 510(k) process. If Amazon asks, you provide the full English label showing the UDI, the device's unique ID code, plus the manuals.

See the plan for your product →

This page covers medical devices sold to consumers, such as thermometers, blood-pressure monitors and other low-risk diagnostic tools. Prescription devices and ones for professional use only sit outside this page; the free check in the plan tells you which rules apply to yours.

What does Amazon ask for before you list a medical device?

  • Amazon has to approve you for medical devices before you list.1
  • If asked: images of the full English label with the UDI (the device's unique ID code), and the manuals.2
  • The device must be FDA registered and listed. Where required, it must be 510(k) cleared (FDA's clearance before sale).2
If you sell into California
  • Decide whether the product needs a Prop 65 warning. If it does, set the warning type and chemical names on the Compliance tab.3
  • Set it on each child SKU, not the parent. Amazon applies this even with fewer than 10 employees.3
Also on Amazon for this product (1)
  • Don't send Amazon labels or signs.3
Sources (3) · read 27 Sep 2026
  1. 1Amazon help, “Categories and products that require approval”
  2. 2Amazon help, “Medical devices and accessories”
  3. 3Amazon help, “California Proposition 65”

What does the law ask for, whatever the marketplace?

  • The foreign maker must be registered and the device listed, or it can't be imported.1
  • A 510(k), where the device type needs one. That's FDA's clearance before the device is sold. A distributor can rely on the maker's.2
  • A UDI (the device's unique ID code) on the label.3
  • Keep complaint files. As the importer, report deaths or serious injuries within 30 days.4
If you sell into California
  • California requires a clear warning before anyone is exposed to a chemical on its list.5
More the law asks for this product (2)
  • Businesses with fewer than 10 employees are outside the law.6
  • This plan doesn't yet say how or where to warn: on the label, in a notice to stores, or online. That waits until the official rules are read.
Sources (6) · read 27 Sep 2026
  1. 121 CFR 807.40(c), foreign establishments. eCFR text as of 1 Sep 2026
  2. 221 CFR 807.85(b), 510(k) exemption for a distributor. eCFR text as of 1 Sep 2026
  3. 321 CFR 801.20, UDI. eCFR text as of 1 Sep 2026
  4. 421 CFR 803.18 and 803.40, complaint files and reports. eCFR text as of 1 Sep 2026
  5. 5Cal. Health & Safety Code 25249.6. California code
  6. 6Cal. Health & Safety Code 25249.11(b). California code

What does that look like for one device?

Say you import a blood-pressure monitor to sell on Amazon. The maker must already be registered with the FDA and the device listed. If the device type needs one, it also needs 510(k) clearance, the FDA's sign-off before sale. Amazon has to approve the listing, and can ask for label images showing the device's UDI and the manuals.

What's the next step?

The plan lists every step for your product in order, with a source for each line. It opens with Amazon and the product type already picked, and you can change either. It's free, with no signup.

See the plan for your product →

Not sure which FDA steps apply? The free certificate check shows them for your product, with the rule cited for each. Check which certificate you need — free →

Related

Checked against Amazon's and the government's own pages on 27 Sep 2026.

Legal Disclaimer

This report is an automated, informational screening tool only. Tiana & Co. is not a licensed customs broker and does not conduct customs business. This report does not constitute legal advice, a compliance determination, or a certification of admissibility for any supplier, product, or shipment.

Verdicts in this report are produced by deterministic code, not by a language model. The explanatory paragraph accompanying each check is model-generated and checked against the cited sources before delivery. No part of this report is reviewed by a person before it is issued, so every material finding and citation should be confirmed against the underlying government source before it is relied on.

This report reflects data available as of the report date. The OFAC SDN and Consolidated lists, the other U.S. Consolidated Screening List constituents, the UFLPA Entity List, CBP withhold release orders, CPSC's eFiling list, and regulatory guidance are updated frequently and without prior notice. Users should re-screen periodically and consult qualified counsel for compliance decisions.

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Use of this report for import, procurement, sanctions-compliance, or investment decisions is at the user's own risk. Anyone with compliance obligations under UFLPA, OFAC, or CPSC regulations should consult qualified legal counsel before making a transactional decision.