FDA Updates Import Alert 99-34: Why Should Buyers Verify Establishment Registration and Product Listing Before Sourcing Medical Devices for the US Market?
A factory being able to manufacture a medical product and that factory or product being legally eligible to enter the US are separate questions. Procurement teams must confirm both before issuing a PO.
Key takeaway
When sourcing medical products for the US market, buyers must verify more than ISO certificates, test reports, and samples. They must also verify establishment registration, device listing, and the actual manufacturing relationship.
FDA Import Alert 99-34 was updated on September 3. For firms and products without valid drug or medical-device registration and/or listing, the FDA may use Detention Without Physical Examination (DWPE).
What should buyers verify before placing an order?
1. Who is the actual manufacturer?
The trading company, brand owner, and manufacturing facility may be different entities. Registration checks must cover the relevant actual establishment.
2. Is the establishment registration valid?
Registration is not a one-time certificate. Buyers should verify its current status and relevant scope of operations.
3. Does the product have the applicable listing?
An establishment being registered does not automatically prove that every model meets product-listing requirements.
4. Are the entities consistent across documents?
The roles of companies shown on the PO, label, invoice, 510(k) or other applicable market-authorization documents, and registration records should be explainable.
Medical-device supplier audit table
| Item | Evidence for buyers |
|---|---|
| Establishment | Actual factory name and address |
| Registration | Current valid status |
| Listing | Record matching the product or model |
| Labeler/Brand | Entity responsible for the label |
| Importer | US import-responsibility arrangement |
| Change control | Notification of factory or model changes |
Why can “the supplier has shipped to the US before” not replace verification?
Past shipments show only that transactions occurred before. They do not guarantee that the current registration status, product listing, or corporate relationships remain valid. Verification is especially important after a change of factory, brand, or model.
Procurement action
Make “US market readiness” a PO-release condition for US orders. Do not enter mass production or make a large advance payment until key registration and listing records have been verified.
Scope and limits
Different medical devices and drugs follow different regulatory pathways. Registration and listing are not the same as complete market authorization or a full compliance conclusion. Each product must be assessed under the applicable FDA classification and rules.
FAQ
Does an FDA registration number mean the product is approved?
No. Establishment registration, product listing, and product market requirements are separate levels.
Is a registration screenshot from a trading company enough?
Buyers should independently check the official database and confirm that the listed entity matches the actual factory.
Which orders most need advance checks?
First-time cooperation, factory changes, model changes, and high-value US orders.