NEW BIS LICENSE TYPES C69 License Exception (MED) – for exports authorized under License Exception Medical Devices (MED)
April 30, 2024
On Monday, April 29, 2024, the Department of Commerce, Bureau of Industry and Security (BIS) published a final rule, Amendment to Existing Controls on Russia and Belarus Under the Export Administration Regulations (EAR) Adding New License Exception Medical Devices (MED); Corrections (https://www.federalregister.gov/documents/2024/04/29/2024-09076/amendment-to-existing-controls-on-russia-and-belarus-under-the-export-administration-regulations-ear) with an effective date of April 29, 2024. This final rule established a new License Exception Medical Devices (MED) in § 740.23 of the Export Administrations Regulations (EAR), 15 C.F.R. parts 730 - 774. This license exception as specified under the paragraph (a) (Scope) authorizes the export, reexport, and transfer (in-country) of “medical devices” designated as EAR99 to or within Russia, Belarus, the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine (as specified in § 746.6(a)(2) of the EAR). Paragraph (a) directs exporters, reexporters, and transferors to see Supplement no. 3 to part 774 – Statements of Understanding under paragraph (a) (Statement of Understanding ‑ medical equipment) for guidance on classifying medical equipment and the definition of “medical device” in § 772.1 of the EAR.
Paragraph (a) also specifies that License Exception MED authorizes the export, reexport, or transfer (in country) to or within Russia, Belarus, the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine of “parts,” “components,” “accessories,” and “attachments” designated as EAR99 that are exclusively for use in or with “medical devices” designated as EAR99. For “parts,” “components,” “accessories,” and “attachments” authorized under License Exception MED, such replacement “parts,” “components,” “accessories,” and “attachments” may only be exported, reexported, or transferred (in-country) if they also meet the additional requirements under paragraphs (a)(1) and (2) of § 740.23.
Exports, reexports, and transfers (in-country) authorized under License Exception MED must not be restricted under § 740.23(b) (Restrictions), which restricts “proscribed persons” and any item destined to a “production” “facility” or when you have “knowledge” that the item is intended to develop or produce items. Exports, reexports, and transfers (in-country) authorized under License Exception MED must also comply with the verification requirements specified in paragraph (c) (Verification) and the recordkeeping requirements specified in paragraph (d) Recordkeeping and review or inspection of records.
As a result of these actions, the following changes will be made to the AES in order for exporters and authorized agents to successfully report electronic export information in the AES.
New License Code C69 License Exception (MED)
An update has been made to AES to create License Type Code C69 MED.
An update has been made to AES to create new License Code C69 “License Exception Medical Devices” (MED), which authorizes certain exports, reexports of any item “medical devices” designated as EAR99 and “parts,” “components,” “accessories,” and “attachments” designated as EAR99 that are exclusively for use in or with “medical devices” designated as EAR99.
The full terms of License Exception MED are described in § 740.23.
AES filers must adhere to the following new reporting when using C69 (MED) to prevent the return of fatal errors from AES:
- Report License Code: C69 MED.
- Allowable ECCNs: No ECCNs are allowed. Only EAR99 is allowable.
- Allowable countries: Belarus, Russia, and Ukraine. (Note that although all of Ukraine is specified as an allowable country in AES, that License Exception MED is only needed to authorize exports exports, reexports, and transfers (in-country) to or within temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine (as specified in § 746.6(a)(2) of the EAR)).
- Allowable Export Information Codes: All except UG
- Allowable Modes of Transportation: All except ‘70’ (Fixed Transport)
A complete list of all of the AES License Codes and reporting instructions for these types can be found at https://www.cbp.gov/document/guidance/aestir-appendix-f-license-and-license-exemption-type-codes
For questions regarding these upcoming AES changes, please contact the Bureau of Industry and Security at one of the phone numbers below.
Outreach and Educational Services Division (located in Washington, DC) (202) 482-4811
Office of Technology Evaluation (located in Washington, DC): (202) 482-4933
Western Regional Office (located in Irvine, CA) (949) 660–0144
Northern California branch (located in San Jose, CA) (408) 998-8806
|
