China Medical Devices

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Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

China's Medical Device Market: Coping with Evolving Regulatory Challenges

Ask a senior manager of a MedTech company in China what keeps her or him awake at night and “regulatory changes” will invariably be among the first things mentioned. In fact, in McKinsey’s 2016 survey of MedTech CEOs,...more

China's Medical Device Market: Coping with Evolving Regulatory Challenges

Ask a senior manager of a MedTech company in China what keeps her or him awake at night and “regulatory changes” will invariably be among the first things mentioned. In fact, in McKinsey’s 2016 survey of MedTech CEOs,...more

Business Litigation Report - July 2016

Article: Increase in Vertical Price Restraint Enforcement in China - In recent months, Chinese anti-monopoly enforcement actions scrutinizing and penalizing pricing-related issues have noticeably increased. A growing...more

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

China FDA Solicits Comments on Priority Review Designation Procedure for Devices

The China Food and Drug Administration (“CFDA”) recently proposed a draft circular to address the priority review designation issue for medical devices, namely the Circular Regarding Soliciting Comments Regarding Priority...more

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules...more

China FDA Announces Good Clinical Practices for Medical Devices

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

Drug and Medical Device Corruption Risks in China

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

China Regulatory Enforcement Quarterly - Q3 2015

On August 12, a series of explosions in the northern port-city of Tianjin killed over one hundred people and injured hundreds of others. The explosions were allegedly caused by hazardous chemical materials in shipping...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

China Tightens Advertising Rules for Life Sciences Companies

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

China FDA Releases Guideline for Medical Device Registration Studies

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

China Introduces New Medical Device GMP and GSP Rules

In December 2014, China’s Food and Drug Administration (“CFDA”) revised the existing provisional Good Manufacturing Practices for medical devices (“New GMP”), and issued the country’s first Good Supply Practices for medical...more

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

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