Proforma Invoice for Medical Supplies: What It Is and How It Differs from a Commercial Invoice

General information about US customs paperwork, not legal or customs-broker advice. The rules below are US import rules (19 CFR); export requirements in other countries differ and are not covered.

Short answer

In US import law, a pro forma invoice is a substitute document. 19 CFR 141.85 sets out its form for a filer who is “not being in possession of a commercial seller’s or shipper’s invoice”, and 19 CFR 141.83(d) allows it only for merchandise on that paragraph’s exempted list, and only when no invoice or bill is available. For medical and laboratory supply orders, the commercial invoice is the document customs expects, and the one to check field by field.

Definition and scope

Two US customs rules define the terms that matter here. Under 19 CFR 141.83(c)(1), a commercial invoice is filed for each shipment of merchandise not exempted by paragraph (d). Under 19 CFR 141.83(d), for merchandise listed there, a commercial invoice is not required. The importer still presents any invoice, memorandum invoice or bill in its possession, and “if no invoice or bill is available, a pro forma (or substitute) invoice, as provided for in § 141.85, shall be filed”. That substitute must contain information adequate to examine the merchandise and determine duties.

The same rules apply to an order of gloves, syringes or reagents as to any other goods. Medical products add companion paperwork, such as the FDA entry declaration covered in FDA Form 2877, which is accompanied by the commercial invoice in English. The entry document itself is explained in CBP Form 3461.

How it is used in practice

The pro forma form in 19 CFR 141.85 asks the filer for:

• names and addresses of the shipper, seller, consignee and purchaser;
• whether the merchandise has been purchased, and the basis for the stated prices;
• case marks, item numbers, quantities and descriptions;
• unit and total purchase or foreign values;
• which charges are included in the prices;
• the country of origin, and the signer’s title, firm and date.

The form also contains the statement “If any other invoice is received, I will immediately file it with an authorized CBP official.” So even where it is accepted, it stands in for the real invoice until one exists.

Proforma vs commercial invoice (US customs rules)

Point	Commercial invoice	Pro forma invoice
Governing section	19 CFR 141.83(c)(1) and 141.86	19 CFR 141.83(d) and 141.85
When filed	For each shipment not exempted by 141.83(d)	Only for merchandise listed in 141.83(d), when no invoice or bill is available
Content	Field list in 141.86, including port of entry, itemized charges, per-package contents	Form in 141.85, signed by the filer, with the prices’ basis and whether the goods were purchased
If a real invoice arrives later	Not applicable	Filer undertakes to file it immediately

What to check on a commercial invoice before shipment

19 CFR 141.86 lists what a commercial invoice must show. For a medical or lab order, ask the supplier to confirm each of these against your purchase order:

1. The port of entry to which the merchandise is destined.
2. A detailed description of each item, including the name by which it is known, not only a catalogue code.
3. The marks and numbers of the packages, and the quantities in weights or measures of the country of shipment.
4. The purchase price of each item in the currency of the purchase, and the kind of currency.
5. All charges upon the merchandise itemized by name and amount, including freight and insurance.
6. The country of origin. See certificate of origin for the companion document.
7. What merchandise is in each individual package (141.86(e)).
8. English language: the invoice and all attachments must be in English, or carry an accurate English translation (141.86(d)).

If you receive an advance document before ordering, compare it with this list. Any field the final invoice must show but the advance document omits is a question to put to the supplier early. The valuation side is covered in customs valuation, and supplier paperwork more broadly in the vendor onboarding documentation checklist.

Common misunderstandings

A pro forma invoice can replace the commercial invoice for any shipment

Under the regulation it cannot. The substitute applies to merchandise listed in 141.83(d) when no invoice or bill is available; other shipments need a commercial invoice.

One invoice covers every document requirement

No. FDA-regulated entries also need the customs entry and Form FDA 2877 alongside the English-language commercial invoice.

Summary descriptions are enough

141.86 asks for a detailed description by the name each item is known by, and for per-package contents.

FAQ

What is the difference between a proforma invoice and a commercial invoice for medical devices?

Under US import rules the commercial invoice is the standard document (141.83(c)(1), 141.86). The pro forma form (141.85) is a substitute for specified merchandise when no invoice is available, and is replaced by the real invoice when received. The rules do not treat medical devices differently on this point; FDA entries add Form FDA 2877.

Which invoice applies when exporting medical equipment?

This page covers US import regulation only. Export documentation varies by country, so check the rules of the exporting country with the supplier or a licensed customs broker.

Must the invoice be in English?

Yes for US entry: 19 CFR 141.86(d) requires the invoice and all attachments in English, though an accurate English translation attached also satisfies it.

Sources

• 19 CFR 141.83, Invoice requirements (checked 2026-11-01)
• 19 CFR 141.85, Pro forma invoice (checked 2026-11-01)
• 19 CFR 141.86, Contents of invoices (checked 2026-11-01)