News & Analysis as of

Exports Export Controls Medical Devices

The Volkov Law Group

Commerce Department Promulgates New Rule Adopting Medical Device License Exception for EAR99 Exports to Russia, Belarus and...

The Volkov Law Group on

On April 29, 2024, the U.S. Department of Commerce officially published a final rule in the Federal Register that formally incorporates a medical device license exception into the Export Administration Regulations (“EAR”) for...more

Hogan Lovells

BIS Issues License Exception MED for Russia, Belarus, Crimea, and covered regions of Ukraine

Hogan Lovells on

On April 29, 2024, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) issued a final rule to add a new license exception for medical devices (License Exception MED) to authorize the export, reexport, and...more

Locke Lord LLP

BIS Introduces License Exception MED ‎for Medical Device ‎Exports to Russia, Belarus, and Occupied ‎Ukraine

Locke Lord LLP on

Effective April 29, 2024, the U.S. Department of Commerce's Bureau of Industry and Security (“BIS”) introduced a new export license exception to allow the export of medical devices to or within Russia, Belarus and the...more

Cooley LLP

New License Exception Authorizes Exports of Previously Restricted Medical Devices and Related Items to Russia, Belarus, Occupied...

Cooley LLP on

The US Department of Commerce’s Bureau of Industry and Security (BIS) added a new License Exception for Medical Devices (License Exception MED), effective April 29, 2024, authorizing exports, reexports and transfers of...more

Foley Hoag LLP

BIS Introduces New License Exception for Export of Medical Devices to Russia, Belarus, and Occupied Regions of Ukraine

Foley Hoag LLP on

License Exception MED - On April 25, 2024, the Department of Commerce’s Bureau of Industry and Security (“BIS”) announced a final rule for a new license exception for “medical devices” under § 740.23 of the EAR (“License...more

ArentFox Schiff

BIS Authorizes Medical Device Exports to Russia, Belarus, and Occupied Ukraine (With Strings Attached)

ArentFox Schiff on

License Exception MED, published by the US Department of Commerce’s Bureau of Industry and Security (BIS) on April 25, authorizes the export, reexport, or in-country transfer of EAR99 “medical devices” to non-military...more

The Volkov Law Group

Navigating Recent BIS Changes to the EAR: A Practical Primer for the Medical Device and Product Industry

The Volkov Law Group on

Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more

Jones Day

Trade Controls in the EU: COVID-19 Measures at a Glance

Jones Day on

In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more

Hogan Lovells

Poland enacts new measures in response to COVID-19

Hogan Lovells on

This week new facilitations and limitations in connection with COVID-19 were introduced in Poland. They include the exemption from taxes on import and intracommunity purchase of selected goods and a new ban on the export of...more

Hogan Lovells

The EU and various member states measures on Personal Protective Equipment in response to the COVID-19 outbreak

Hogan Lovells on

In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Spanish

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Russian

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - Chinese

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - October 2018

ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...more

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

Hogan Lovells on

On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

Hogan Lovells

The Obama Administration Eases Sanctions Against Sudan

Hogan Lovells on

On January 13, 2017, the White House, the U.S. Department of Treasury ’s Office of Foreign Assets Control (OFAC) , and the U.S. Department of Commerce ’s Bureau of Industry and Security (BIS) announced a host of policy...more

Arnall Golden Gregory LLP

One Step Up: U.S. Export Controls for Pharma/Device Companies

2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for...more

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