International Traffic in Arms Regulations compliance
Healthcare and life sciences companies exporting medical devices, diagnostic equipment, or dual-use biological technologies face a sharper compliance burden under the International Traffic in Arms Regulations than most legal teams anticipate. The U.S. Department of State Directorate of Defense Trade Controls administers ITAR, but the U.S. Department of Commerce Bureau of Industry and Security frequently intersects on jurisdiction determinations when a product crosses the EAR-ITAR boundary. Misclassification between these two regimes is the leading source of voluntary disclosures from life sciences exporters, and compliance teams are actively auditing product classification files and foreign national access controls before those disclosures become necessary.
Watch
- DDTC's Category XV(f) coverage: does your telemetry hardware qualify as a defense article?
- Foreign national access controls inside domestic R&D and manufacturing facilities
- BIS 600-series EAR controls as an off-ramp from ITAR jurisdiction for certain medical devices
- Voluntary self-disclosure procedures at DDTC following the 2023 penalty settlement pattern
Recent material activity in Healthcare & Life Sciences
Active monitoring in place across Healthcare & Life Sciences. Material developments related to international traffic in arms regulations compliance will appear here as they are published.