News & Analysis as of

Supply Chain Medical Devices Imports

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Gardner Law

What to Do When FDA Detains Your Shipment

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When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

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Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

King & Spalding

EUROPE – European Commission Excludes Chinese Medical Device Manufacturers from EU Public Procurement Contracts

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On June 19, 2025, the European Commission (“EU Commission”) adopted Regulation 2025/1197 imposing restrictive measures on Chinese medical devices in its first use of the European Union’s International Procurement Instrument...more

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more

Foley Hoag LLP

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

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I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

Bricker Graydon LLP

The Impact of Tariffs on Medical Equipment Manufacturing in Kentucky

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In our recent publication, “The Impact of Tariffs on the Insurance Industry,” we explored how the sweeping tariff policy announced by President Donald Trump is affecting various insurance sectors....more

Rivkin Radler LLP

ADA Joins Coalition Seeking Tariff Exemption for Medical and Dental Supplies

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The American Dental Association (ADA) has joined a coalition of other healthcare organizations in writing a letter to U.S. Trade Representative Jamieson Greer urging the Trump administration to exempt medical and dental...more

Baker Botts L.L.P.

Biden Administration Launches Section 301 Investigation into Chinese Semiconductor Industry

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On December 23, 2024, the Biden administration announced that the Office of the U.S. Trade Representative ("USTR") is launching a new investigation into China's trade practices with respect to the semiconductor industry. In...more

Miller Canfield

USTR Finalizes New Section 301 Tariffs

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The United States Trade Representative (USTR) published a Federal Register notice detailing its final modifications to the Section 301 tariffs on China-origin products....more

Lowenstein Sandler LLP

USTR Finalizes Section 301 Tariff Modifications Following Four-Year Review

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On September 13, the Office of the U.S. Trade Representative released a Federal Register notice detailing final modifications to Section 301 tariffs on Chinese imports following its statutorily mandated four-year review. Key...more

Wiley Rein LLP

USTR Releases Final Section 301 Modifications in Four-Year Review

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On September 13, 2024, the Office of the U.S. Trade Representative (USTR) released the text of a Federal Register notice explaining the final modifications that will be made as a result of the statutory four-year review of...more

Hogan Lovells

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

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In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more

Smart & Biggar

Health Canada – COVID-19 update highlights

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Society of Corporate Compliance and Ethics...

A look at the EU Market Surveillance Regulation

Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more

BakerHostetler

FDA and Pharmacy Weekly Digest - October 2020 #1

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FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more

Holland & Knight LLP

FinCEN Warns of Scams Relating to PPE and Other Medical Goods During COVID-19 Pandemic

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In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more

Polsinelli

COVID-19 Challenges Medical Equipment Supply Chains

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The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more

McDermott Will & Schulte

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

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

EU suspends tariffs on medical equipment

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Following requests from numerous Member States, on 3 April the European Commission (“Commission“) adopted Commission Decision (EU) 2020/491 (“the Decision“), which provides for relief from import duties and VAT for goods...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

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

DHSC Update on Medicines and Medical Devices Contingency Planning

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Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

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On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

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