US BIS adds License Exception MED for EAR99 medical-device exports to Russia, Belarus and Russia-occupied regions of Ukraine

Mechanism

Codified at 15 CFR 740.23, License Exception MED is a humanitarian carve-out inside the post-2022 EAR Russia/Belarus perimeter. It authorises export, reexport and in-country transfer of EAR99 medical devices (and EAR99 parts/components/accessories solely for use with EAR99 medical devices) to Russia, Belarus, occupied Crimea, and the other "covered regions" of Ukraine without applying for an individual BIS licence. The rule preserves the broader EAR99 luxury/industrial prohibitions for Russia/Belarus by carving out only the medical sub-set that BIS had been "regularly approving" on a licence-by-licence basis since 2022 — the rule effectively normalises that practice.

Key conditions:

• Recipient may not appear on the Entity List, MEU/MIEU lists, or

otherwise be a prohibited party.

• The items cannot be destined for a "production facility".
• Exporters must verify end use and end user (explicit verification

obligation in the regulation text).

• Diversion of medical devices to weapons-related production or

development voids the exception.

Companion Federal Register notice (FR Doc 2024-09076) also issues technical corrections to earlier Russia/Belarus EAR amendments.

Downstream implications

• Removes a recurring compliance bottleneck for US/EU medical-device

exporters (GE Healthcare, Medtronic, Abbott, BD, Siemens Healthineers via US-origin content, Philips US-content) who had been routing Russian-market sales through individual BIS licences since 2022.

• Aligns US humanitarian carve-out posture with parallel OFAC General

Licences for medical-device shipments under the Russian Harmful Foreign Activities Sanctions program, reducing the divergence between EAR and OFAC perimeters.

• Severity calibrated at 2: the rule is a perimeter relaxation, not an

escalation, but the affected trade is non-trivial (~USD 1.5-2bn pre-war US medical-device exports to Russia) and the verification obligation creates ongoing compliance workload.

Open questions

• Does BIS expect to expand License Exception MED to other comprehensively-

sanctioned destinations (Iran, North Korea, Syria) where humanitarian exceptions already exist via OFAC general licences but EAR controls remain restrictive?

• What share of pre-rule licence applications were being denied vs.

approved? The FR preamble implies a high approval rate, which is the justification for codifying the exception.