News & Analysis as of

Exports Medical Devices

The Volkov Law Group

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

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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

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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

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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

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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

Smart & Biggar

Updates to Health Canada’s regulatory initiatives for 2022-2024, and amendments to Food and Drug Regulations (Exports and...

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Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more

McDermott Will & Emery

Brexit and COVID-19: Changes to the Regulation of Medicines

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The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020, the UK Government made changes to...more

White & Case LLP

COVID-19: Summary of Legal Measures in Russia

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This summary is intended to help clients navigate the large number of legal measures taken expeditiously by the Russian authorities in connection with the spread of COVID-19. The summary is not exhaustive. It includes only...more

White & Case LLP

COVID-19: Key Issues When Sourcing Pandemic Prevention Supplies from China

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Pandemic prevention supplies are in high demand during the current coronavirus disease (“COVID-19”) outbreak. China, as it gradually gets the outbreak under control, is resuming manufacture and exporting the supplies to the...more

McDermott Will & Emery

International News: COVID-19 Global Pandemic - May 2020

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The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Jones Day

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

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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

K&L Gates LLP

COVID-19: New FEMA Rule Limits U.S. Export of Personal Protective Equipment

K&L Gates LLP on

The U.S. Federal Emergency Management Agency (FEMA) has issued a temporary rule, pursuant to Section 101 of the federal Defense Production Act (DPA), under which FEMA will review and limit export shipments of five types of...more

Vinson & Elkins LLP

U.S. Government Restricts Exports Of Respirators, Masks And Gloves During Pandemic

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On April 7, 2020, the Federal Emergency Management Agency (“FEMA”) issued a temporary final rule to restrict exports of respirators, masks and gloves used by healthcare providers. The restrictions, which will remain in effect...more

McDermott Will & Emery

[Webinar] Critical Business Considerations for Life Sciences and Medical Device Companies Amid the COVID-19 Pandemic - April 17th,...

McDermott Will & Emery on

Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more

Hogan Lovells

Poland enacts new measures in response to COVID-19

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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

Trump invokes Defense Production Act to block exports of Personal Protective Equipment

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With reports of widespread shortages of personal protective equipment (PPE) and ventilators and the COVID-19 pandemic continuing to expand nationwide, the Trump Administration has turned to the Defense Production Act (DPA) –...more

Seyfarth Shaw LLP

Federal Government Adopts New Process for States and Tribes to Request Ventilators from the Limited Federal Supply

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On April 1, 2020, a FEMA advisory issued that announced a new, more formalized process for distributing the limited available supply of ventilators to states and tribes.  The federal government’s supply of available...more

Foley Hoag LLP

COVID-19 Impacts on Trade, Export Controls, and Supply Chain

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Updates from March 11 to March 25, 2020 - Key Takeaways: Supply chain disruption has begun on some fronts that are not directly related to the healthcare and medical fields, and is anticipated to continue as the effects...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

White & Case LLP

COVID-19 – First EU trade measures focus on health supply, basic needs

White & Case LLP on

In an effort to secure continued supply of goods within the EU during the COVID-19 crisis, the EU has taken a number of initial actions with a focus on essential health products and food. So far, these EU actions include 1)...more

McDermott Will & Emery

COVID-19 – Legal Implications for Pharmaceutical and Medical Device Companies in Germany

McDermott Will & Emery on

The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

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When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Hogan Lovells

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

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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

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