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Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Life Sciences Spotlight - Issue 4, 2014

Since our last edition, there has been a number of developments in the Life Sciences sector across the Asia Pacific region and we are pleased to be able to update you on these recent trends. It is evident that the...more

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s...more

China Amends Key Medical Device Regulations

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

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No....

China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”). The State Council...more

US China Trade War Newsletter

Dear Friends, There have been major developments in the trade, solar cells, US/Chinese antitrust, and securities areas. REASON FOR THIS NEWSLETTER - Some readers have commented that this newsletter is...more

China Amends Regulations on Supervision and Management of Medical Devices; Prior Marketing Approval Requirement to Import Medical...

On March 31, 2014, China Premier Mr.Li Kequiang signed Decree No. 650 on the amended Regulations on Supervision and Management of Medical Devices (“the amended regulations”), which update the original regulations1 released in...more

China Overhauls Regulation on the Medical Device Industry

The Chinese Central Government recently adopted material amendments to the Regulation on the Supervision and Administration of Medical Devices, which will bring significant changes for medical device companies operating in...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

China Introduces Major Changes to Medical Device Regulations

On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more

China Tightens Supervision and Enforcement in the Medical Device Sector

On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more

China Releases Fast Track Approval Process for Innovative Medical Devices

On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration (the “CFDA”) recently published a draft regulation, Good Supply Practices for Medical Devices (the “Draft GSP”), for public comment through January 20, 2014. The first-ever regulation...more

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

Letter From China-Interview With Amy Sommers

Ed. Note-this article is one of a continuing series of interviews of thought leaders in FCPA, Bribery Act and anti-corruption/anti-bribery. In this blog post, I interview Amy Sommers, partner in the Shanghai office of K&L...more

Red Notice Newsletter - November 2013

INTRODUCTION - Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more

China Enhances Regulatory Oversight of Medical Device Studies and Vigilance

The China Food and Drug Administration (“CFDA”) recently introduced two important initiatives concerning medical devices. 1) The Tentative Rules on the Review and Approval of Medical Device Clinical Studies (Draft) was...more

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

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

Astros Swept Again – Is A China Sweep Coming Next?

What is a sweep? It is certainly a well-known and relevant term in the sporting world....more

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

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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