News & Analysis as of

Supply Chain China Medical Devices

White & Case LLP

EU imposes first International Procurement Instrument measure restricting Chinese access to medical devices procurement

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Adopted in 2022, the IPI allows the Commission to investigate alleged non-EU country measures or practices against EU economic operators that limit access to the public procurement and concession markets of non-EU countries....more

A&O Shearman

EU restricts Chinese access to public procurement of medical devices

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Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...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

Ropes & Gray LLP

2025 Medtech Regulatory Affairs Roundtable: Key Takeaways

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On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and...more

Knobbe Martens

Medtech Leaders Speak Out On Impact of Global Tariffs

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Some Medtech companies recently addressed the potential impact of global tariffs in their Q1 2025 earnings calls. Johnson & Johnson and Abbott were among the first to speak on the implications of these tariffs and how their...more

Knobbe Martens

U.S. Tariffs and the Medical Device Industry

Knobbe Martens on

As of April 25, 2025, the U.S. has imposed tariffs on over 180 countries and territories. This includes a universal 10% baseline tariff while larger tariffs are in a 90-day “pause” period. The tariffs may impact many...more

Baker Botts L.L.P.

Biden Administration Launches Section 301 Investigation into Chinese Semiconductor Industry

Baker Botts L.L.P. on

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

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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Hogan Lovells

The TGA and the Iron Mask

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In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

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China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

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The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

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The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

Hogan Lovells

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

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On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more

McDermott Will & Emery

China Solicits Comments on Good Supply Practices for Medical Devices

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The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more

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