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Medical Devices Imports

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

WilmerHale

Federal Circuit Addresses Scope of Medical Device and Drug Infringement Safe Harbor

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On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more

Dunlap Bennett & Ludwig PLLC

Apple Watch Imports (Possibly) Banned By The ITC: What Patent Owners Need To Know

Regular consumers now enjoy a front-row seat to the long-running intellectual property dispute between Apple, the tech giant based in Cupertino, California, and Masimo, a medical device company based in Irvine, California....more

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

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The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more

Baker Donelson

Certain Health Care Products Could Have Section 301 Duties Reinstated

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The United States Trade Representative (USTR) is likely to reinstate Section 301 tariffs on 81 COVID pandemic-related products. The 81 health care products that will be affected include, but are not limited to, these items: ...more

Epstein Becker & Green

Unpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter...more

Akin Gump Strauss Hauer & Feld LLP

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

Holland & Knight LLP

USTR Extends Section 301 Exclusions for COVID-19 Related Medical-Care Products

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The Office of the U.S. Trade Representative (USTR) published a Notice in the Federal Register on Nov. 16, 2021, extending product exclusions for COVID-19-related products covered by USTR's Section 301 investigation into...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

Arnall Golden Gregory LLP

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration...

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence...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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....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

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

Arnall Golden Gregory LLP

We Have Come Full Circle: FDA Will No Longer Authorize Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China

On October 15, 2020, the Food and Drug Administration announced that it had reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) manufactured in China that are not approved by the...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

Faegre Drinker Biddle & Reath LLP

FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...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

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

Seyfarth Shaw LLP

FDA Updates Emergency Use Authorization For Chinese Respirators

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Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

McDermott Will & Emery

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

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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

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