AI Today in 5: August 7, 2025. The US v. China Episode
Compliance into the Weeds: A Deep Dive into Cadence Design Systems’ Export Control Violations
10 For 10: Top Compliance Stories For the Week Ending, August 2, 2025
Daily Compliance News: August 1, 2025, The All AI Edition
Daily Compliance News: July 25, 2025, The New Sheriff in Town Edition
All Things Investigations – Navigating Secondary Tariffs with Mike Huneke and Brent Carlson
FCPA Compliance Report: The Impact of Secondary Tariffs on Global Trade with Mike Huneke and Brent Carlson
Daily Compliance News: July 21, 2025, The More Reasons Not to Go to China Edition
Regulatory Ramblings: Episode 73 - Geopolitical Risk: Thai Tensions / Sanctions, Tariffs & FCPA Enforcement in Asia
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Regulatory Ramblings: Episode 71 – Crypto Fault Lines: Stablecoins, Meme Coins & the Fight for Clarity PLUS: Sanctions, Shell Companies & Fragmented Global Trade
Episode 372 -- DOJ Applies False Claims Act to Tariff and Trade Violations
Hot Topics in International Trade - Tariff Mitigation Strategies
Daily Compliance News: May 30, 2025, The Leissner Sentenced Edition
Regulatory Ramblings: Episode 70 – Lessons for Compliance from a Law Enforcement Career + Regional Geopolitical Risks in 2025 with Mark Nuttall and Steve Vickers
Daily Compliance News: May 21, 2025, The I Want You Back Edition
Hot Topics in International Trade Terrified by Tariffs Braumiller Law
2 Gurus Talk Compliance: Episode 52 – The Big Jet Plane Edition
10 For 10: Top Compliance Stories For the Week Ending May 10, 2025
Daily Compliance News: May 6, 2025 the Made in China Edition
Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and...more
Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...more
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
The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...more
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
ADA Advocating for Fluoridation, Says Medical Devices Should Not Be Subjected to Tariffs - The dental industry and DSOs are experiencing change as both continue to embrace technology, including AI. The political and...more
Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more
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
On January 14, 2025, China issued the final version of its compliance guidelines for health care companies to prevent commercial bribery risks (“Guidelines”), which took effect immediately. The Guidelines are applicable to...more
The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more
On January 10, 2025, China’s State Administration for Market Regulation (SAMR) officially released the Compliance Guidelines on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (the Guidelines). This...more
On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more
On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more
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
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
As the coronavirus (COVID-19) spreads across the world, creating new epicenters, this is perhaps an opportune moment to look back at the lessons learned from China, where it appears that the outbreak is under control, in...more
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
Ransomware Attacks Predicted to Occur Every 11 Seconds in 2021 with a Cost of $20 Billion - Confirming what we are seeing in the field, cybersecurity firm Cybersecurity Ventures has predicted that, globally, businesses in...more
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