Usually, yes. The foreign company that makes a drug or a medical device for the U.S. registers with FDA and lists the product. For a device, the U.S. importer registers too. Registering isn't FDA approval; that's a separate step.
Yes, for most. Foreign makers, repackers, relabelers and salvagers of human drugs register their site with FDA and list their drugs, unless an exemption applies. It tells FDA who makes what. It doesn't replace any other FDA rule.
Two things happen. The foreign maker registers its site and lists its devices. And the U.S. initial importer registers too: that's the importer who passes the device on toward the final sale without repacking or relabeling it.
For a device it didn't design or relabel, the importer can list it by giving the maker's name and address. Everything goes through FDA's online registration and listing system.
Every year between October 1 and December 31, when registration is renewed and device listings are reviewed. A change to the registration is due within 30 days. A lapsed listing tends to show up at the border, not in the office.
No. It's an identity and inventory step. FDA says plainly that registering and listing don't mean it approved or cleared the product, judged it safe, or even decided it's a device. Approval for a drug, or clearance or approval for a device, is a separate question.
These two rules cover drugs and medical devices only. Cosmetics, food and other products follow other FDA rules, so being left out here doesn't mean a product is free of FDA rules.
Selling a drug or a medical device? The free certificate check shows the FDA registration and listing steps that apply, with the rule, alongside the CPSC and FCC checks for the same product.
Check which certificate you need — free →The plan puts every step for your product in order, from the supplier to customs and the marketplace, with a source for each line. It's free, with no signup.
See the plan for your product →The rules on this page do change — an eFiling date, a list, a threshold. Leave an email and a short note goes out if one does: a few a year at most, one click to stop, and the address is used for nothing else. A summary of the guide and a link arrive now, as confirmation.
Information current as of 2026-10-21.
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.
Name-similarity results do not establish or rule out the identity of any company. Where multiple similarly named records exist, none should be treated as confirmed without independent verification against the primary government source.
This tool is not affiliated with, endorsed by, or a substitute for U.S. Customs and Border Protection, the U.S. Department of the Treasury, the Consumer Product Safety Commission, or any other government agency. No warranty is made as to the accuracy, completeness, or currency of any finding.
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.
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.
Name-similarity results do not establish or rule out the identity of any company. Where multiple similarly named records exist, none should be treated as confirmed without independent verification against the primary government source.
This tool is not affiliated with, endorsed by, or a substitute for U.S. Customs and Border Protection, the U.S. Department of the Treasury, the Consumer Product Safety Commission, or any other government agency. No warranty is made as to the accuracy, completeness, or currency of any finding.
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.