China, Regulatory Requirements, Filing Requirements

Further Changes to Shipments under $800 from China

Husch Blackwell LLP on 4/14/2025

On April 2, 2025 we reported that imports from China valued at $800 or less would no longer qualify for de minimis treatment starting May 2, 2025. On April 9, 2025 we reported the increase in tariffs and fees for imports of...more

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

K&L Gates LLP on 6/30/2020

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

NYDFS Requires Filing of Preparedness Plans and Financial Risk Assessments Related to COVID-19

Ballard Spahr LLP on 3/17/2020

In an Industry Letter, the New York State Department of Financial Services (NYDFS) is requesting assurance that New York State regulated institutions have preparedness plans in place to address operational risk, and it is...more

SEC Provides Conditional Regulatory Relief and Assistance for Companies Affected by the Coronavirus Disease 2019 (COVID-19)

Herbert Smith Freehills Kramer on 3/5/2020

On March 4, 2020, the Securities and Exchange Commission (the Commission) announced that it is providing conditional regulatory relief for certain publicly traded company filing obligations under the federal securities law in...more

Overview of Medical Device Regulation in China

Morgan Lewis on 3/2/2020

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

Guilty Pleas Highlight Illicit Funneling of Chinese Cash to Casinos

Ballard Spahr LLP on 2/7/2020

Government Suggests that Unusual Pleas are Just the Tip of an Iceberg - Chinese law generally prohibits its citizens from converting more than $50,000 in Chinese yuan into foreign currency in a year. On Monday, two men...more

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