Venezuela Medical Device Regulation: OFAC General License 4C and Payment Channels

1. Key takeaways

The US Department of the Treasury’s Office of Foreign Assets Control (OFAC) General License 4C (GL 4C) authorizes the export or re-export to Venezuela of agricultural commodities, medicines, medical devices, medical device replacement parts and software updates. Medical devices are defined by reference to section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

The core conclusion is that GL 4C authorizes the act of export; it does not resolve payment, and it does not cover counterparty screening. Reading the authorization to export as an authorization to transact is one of the most dangerous misreadings in Venezuelan projects. The two questions are governed by different rules, are answered by different documents, and are checked by different functions inside a company.

The practical consequence is that a compliant export can still leave a manufacturer with funds it cannot lawfully receive, or with a counterparty it should not have dealt with. Both failures are identified after the goods have shipped, which is precisely when they are most expensive to unwind.

2. Legal basis

Jurisdiction note: GL 4C and 31 CFR Part 591 are US rules with extraterritorial reach. For a Chinese manufacturer, whether they apply depends on the existence of a US nexus (dollar settlement, US-origin content, a US intermediary, participation by a US person, and similar factors). Applicability must be determined case by case, with advice from a qualified sanctions compliance counsel. This article does not constitute legal advice.

3. Expert insights

Insight 1: the scope of GL 4C does not coincide with Venezuela’s own regulatory scope. GL 4C defines medical devices under US law, while Venezuela defines the device scope under its own framework. The two may diverge: a product within Venezuela’s regulatory scope does not necessarily fall within the GL 4C authorization, and the reverse is equally true. For projects with a US nexus, both lists must be checked separately, and the result recorded, because the two checks answer different questions and one cannot substitute for the other.

Insight 2: the 50% rule means that name screening alone does not discharge the compliance duty. Under OFAC’s 50% rule, an entity owned 50% or more in aggregate, directly or indirectly, by one or more blocked persons is itself treated as blocked, even if it does not appear on the SDN List. Counterparty screening must therefore penetrate the ownership structure; comparing names is not sufficient. For Venezuelan local partners, this ownership tracing matters particularly, because corporate structures are often layered and the beneficial owners are not visible at the first tier.

Insight 3: the reporting duty has a defined deadline. Where a transaction is blocked because it involves an SDN-listed party or another blocking circumstance, the person holding the property must report to OFAC within 10 business days. The same 10 business day deadline applies where a transaction is rejected rather than blocked. In addition, a person holding blocked property must file an annual report covering holdings as of 30 June, submitted by 30 September. These are short deadlines that require a pre-agreed internal escalation route; an organisation that discovers the obligation while drafting the report will usually miss the date.

Insight 4: sanctions policy is in a state of high-frequency change. E.O. 14373 was issued on 9 January 2026; the national emergency was continued on 18 February 2026; GL 46, GL 46B and GL 52 were issued between January and March 2026; GL 5X was issued on 18 June 2026 and GL 5Y, which replaced GL 5X, on 3 August 2026. A general license can be revoked at any time, so current validity must be confirmed before relying on any license. For planning purposes this means authorizations should be treated as time-limited facts to be re-checked, not as settled conditions of the project.

Insight 5: the humanitarian exemption does not displace other compliance duties. The note to GL 4C states expressly that the general license does not relieve any person of the obligation to comply with other federal laws or the requirements of other federal agencies. Exporting medical devices may also engage the export control rules of the US Department of Commerce Bureau of Industry and Security (BIS), which must be confirmed separately. A manufacturer that clears the OFAC question has cleared one gate, not all of them.

4. Practical recommendations

1. Before the project starts, complete a US nexus assessment and determine which sanctions rules apply; where a nexus exists, engage qualified sanctions compliance counsel.
2. Screen Venezuelan local partners on a look-through basis, covering ownership structure and the 50% rule, rather than comparing names against the SDN List alone.
3. Check item by item whether the product falls within the GL 4C authorization (as defined by 21 U.S.C. 321), and confirm that GL 4C is currently in force.
4. Establish a reporting mechanism for blocked and rejected transactions that can meet the 10 business day deadline.
5. Design the payment channel solution and the export authorization separately, and confirm each on its own terms; do not assume that one covers the other.

5. Verification checklist

• □ US nexus assessment completed and applicability of the sanctions rules determined
• □ Local partners screened on a look-through basis, including the 50% rule
• □ The product has been checked against the GL 4C authorization scope (per 21 U.S.C. 321)
• □ Current validity of GL 4C confirmed (a general license may be revoked)
• □ A 10 business day reporting mechanism for blocked or rejected transactions is in place
• □ The payment channel solution has been designed and confirmed independently of the export authorization

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers, importers and authorized representatives with registration work in Venezuela, including sanctions-adjacent documentation review and coordination with qualified counsel on export and payment structuring. Whether you need a compliance documentation check or hands-on filing support, our regulatory team can help. Contact us at info@grzanglobal.com.