News & Analysis as of

China Medical Devices

Morgan Lewis

Shanghai’s 2024 Enforcement Framework on Healthcare Practices – Key Takeaways and How to Prepare

Morgan Lewis on

The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more

DLA Piper

China: New Definition and Guidelines on Sensitive Personal Information Now Finalised

DLA Piper on

We previously wrote about proposed changes to the definition of sensitive personal information under a June 2024 draft of the Guide for Sensitive Personal Information Identification (“Guide“). The Guide has now (September...more

Miller Canfield

USTR Finalizes New Section 301 Tariffs

Miller Canfield on

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

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

Hogan Lovells on

This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

White & Case LLP

Biden Administration Expands Section 301 Tariffs on Imports from China, Targeting Green Energy, Metals, Minerals, Port Cranes,...

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On May 14, 2024, the Biden administration announced expansions to the United States’ Section 301 tariffs on imports from China, proposing to raise tariffs on solar panels, electric vehicles, batteries, green energy supply...more

White & Case LLP

A new European trade tool: The first investigation under the International Procurement Instrument

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The European Commission has launched its first investigation into a non-EU country's procurement practices leveraging its new tool, the International Procurement Instrument. This investigation looks at the public procurement...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Hogan Lovells

JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

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Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more

Hogan Lovells

Regulation of drug and medical device advertising in China: an industry under the microscope

Hogan Lovells on

In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of products to China include...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

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

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The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Holland & Knight LLP

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

Holland & Knight LLP on

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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 17

China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 10

PA Health Dept Sued; Investigation Looms, After Contact Tracing Breach "The PA health dept. is being sued, after employees of its vendor Insight Global set up an unsecured channel to share COVID-19 contact tracing data,...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

Morgan Lewis on

China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...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 PLLC

FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA

Harris Beach 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

Dechert LLP

fintech NEXT: Developments on Digital Assets and Blockchain

Dechert LLP on

Blockchain technology continues to mature and gain acceptance for a wide range of potentially disruptive financial and commercial uses. In the wake of COVID-19, we have seen an increased focus on the research and development...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 Manufactured in China

On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...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

Knobbe Martens

Balancing Intellectual Property (IP) Interests with National Interest in Response to the Coronavirus

Knobbe Martens on

Traditionally, it has been fairly uncommon to see new legislation in intellectual property (IP) law, compared to other areas of law. Instead, courts have generally been the avenue through which changes in IP law have been...more

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