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Regulatory Requirements China Medical Devices

Hogan Lovells

2025 NMPA Inspection points for clinical trials of medical devices

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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

Hogan Lovells

EU adopts restrictions on access of Chinese companies to EU public procurement for medical devices

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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

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

Knobbe Martens

European Union Votes to Curb China’s Access to Medical Device Market

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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

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

Benesch

Dental/DSO Intelligence Monthly Report: March/April 2025

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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

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

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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

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

Hogan Lovells

China’s first compliance guidelines to prevent corruption risks in the life sciences industry

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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

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

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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

Faegre Drinker Biddle & Reath LLP

China Issues Final Compliance Guidelines in Regulating the Medical Industry

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

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

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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

White & Case LLP

First International Procurement Instrument case relating to EU medical devices in China’s public procurement market. The key...

White & Case LLP on

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

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

K&L Gates LLP

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

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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

Hogan Lovells

China takes a pragmatic approach to relaxing regulation of the life sciences sector during COVID-19

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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

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

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - February 2020 #2

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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

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

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