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Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

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The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Knobbe Martens

U.S. Tariffs and the Medical Device Industry

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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

Hogan Lovells

Why medical device companies must prioritize compliance with DOJ's Data Security Program

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This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

K&L Gates LLP

Five Things to Know About the Changes to China's Medical Device Regulation

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On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more

K&L Gates LLP

Impact of the Growing Marketing Authorization Holder Pilot Program in China's Medical Device Industry

K&L Gates LLP on

This article reveals the mechanics of a growing pilot program for registration of Class II and Class III medical devices to be contract manufactured in China that has gained significant recognition across China over the past...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

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

Harris Beach Murtha PLLC

FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA

Harris Beach Murtha PLLC on

The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more

K&L Gates LLP

Market Entry and Real World Data – China’s Medical Device Industry

K&L Gates LLP on

The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China

Wilson Sonsini Goodrich & Rosati on

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Knobbe Martens

Trump’s Chinese Tariffs Could Cost Medical Device Makers $138 Million Per Year, MITA Says

Knobbe Martens on

President Donald Trump’s 25 percent tariffs on Chinese imports went into effect on July 6, a move that, according to industry experts, could have wide-ranging effects on American medical device manufacturers. In early April,...more

Hogan Lovells

The life sciences industry under the antitrust spotlight in China: two practical points

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The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

K&L Gates LLP

China Amends Key Medical Device Regulations

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The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

The Volkov Law Group

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

The Volkov Law Group on

In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

The Volkov Law Group

Pharmaceutical And Medical Device Companies: Taking It On The Chin (Part II Of III)

The Volkov Law Group on

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more

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