GET TAA Compliant for Medical Equipment and Products in GSA Contracts

You sold what you thought was compliant medical equipment through a GSA Schedule. Months later, you’re under audit, or worse — named in a False Claims Act case.

If you’re selling medical devices or supplies to federal agencies, especially through the GSA Schedule or VA FSS, your product’s country of origin isn’t just a formality. It can determine whether you keep the contract, face investigation, or deal with reputational damage.

TAA compliance isn’t always straightforward. And in the medical supply space — where sourcing shifts and global parts are common — it’s easy to get wrong, even with good intent.

When selling medical equipment or devices to the federal government under GSA contracts, getting Trade Agreement Act compliant is critical for both the equipment and the end products. The Trade Agreements Act (TAA), 19 USC 2501 sets forth specific regulations that govern the eligibility of products to be sold to the government.

What TAA Compliance Means for Medical Equipment Suppliers

When you certify your products as TAA compliant under a GSA Schedule, you’re confirming that:

• The product was wholly manufactured in the U.S., or

• It was substantially transformed in a designated country

But substantial transformation — especially for medical devices assembled with imported components — is where many contractors face risk.

If your supplier assembles imported parts in Mexico, for instance, that may not be enough. The SBA, DOJ, or GSA could still determine the true origin is a non-designated country like China — exposing you to contract termination or worse.

Examples of Non TAA compliant countries include China, India, Indonesia, Iran, Iraq, Malaysia, Pakistan, and Russia. If you are a  GSA Schedule contractor, you must understand “substantially transformation” and the “Country of Origin” for each product and service under your GSA TAA compliance rules. This is especially important for Dealers, Resellers , and manufacturers who do not control the manufacturing process and often rely on box markings and incomplete information.

When medical products and equipment do not comply with TAA requirements – 19 USC 2501-2581, whistleblowers and agencies may report the company to federal healthcare fraud law enforcement. As a result, an TAA compliance investigation starts and you are then subject to the reach of the federal government and even being charged / indicted for a felony.

In one case, the DOJ claimed that a manufacturer knowingly manufactured medical products in China and Malaysia for sale to the Departments of Defense and Veterans Affairs despite the Trade Agreements Act prohibition. In that case, Ambu, a provider of medical supplies, submitted false claims to the Defense Logistics Agency (“DLA”) and the Department of Veterans’ Affairs (“VA”) for payment relating to its sales of medical supplies. The Trade Agreements Act (“TAA”) requires that medical products sold to the. federal government agencies must come only from countries with which the United States has a trade agreement.  While many international countries qualify as TAA compliant countries, China and Malaysia do not.  Ambu began manufacturing its products in these countries and selling them to government agencies in violation of the TAA. 

When TAA Compliance Becomes a False Claims Act Problem

Federal agencies aren’t just canceling contracts — they’re pursuing False Claims Act cases when they believe companies knowingly misrepresented origin.

Medical suppliers have faced:

• Civil Investigative Demands (CIDs)

• Subpoenas

• Target letters

• And even criminal referrals

If your company has claimed U.S. origin for equipment substantially made in China or India, the government can allege that your GSA certifications were false — even if a third party filled out the paperwork.

Tip: If you’ve already received a subpoena or CID, don’t engage directly with investigators without legal counsel. Early statements can shape how your intent is interpreted.