News & Analysis as of

China Medical Devices

China FDA’s Device Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) has published its proposed amendment of the Medical Device Regulations (MDR), previously known as the State Council Order # 650, for public comments. This Alert summarizes the key...more

CFDA Issues New Classification Catalogue for Medical Devices In China

by Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

China’s Central Government Unveils Final Policy for Drug and Device Regulatory Reform

by Ropes & Gray LLP on

Based on the CFDA’s policy proposals published in May 2017, China’s central government announced its final policy for drug and device regulatory reform on October 8, 2017 (“Final Policy”). The Final Policy reiterates the...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

China FDA Updates the Medical Device Classification Catalogue

by Ropes & Gray LLP on

On August 31, 2017, the China Food and Drug Administration (“CFDA”) announced the final revision to the 2002 Medical Device Classification Catalogue (“2002 Catalogue”). The revised version (“New Catalogue”), which will become...more

Implementing China’s Cybersecurity Law

by Jones Day on

China’s Cybersecurity Law was issued on November 7, 2016, by the Standing Committee of the National People’s Congress, and it came into effect on June 1, 2017. The Cybersecurity Law marks the first comprehensive law in China...more

Major IP reforms foreshadowed in China’s Pharma sector

by Hogan Lovells on

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more

China Announces Amendments to Regulation on the Supervision and Administration of Medical Devices

by Ropes & Gray LLP on

On May 19, 2017, China’s State Council promulgated the amendments to the 2014 Regulation on the Supervision and Administration of Medical Devices (“the Amendments”), which became effective immediately. The Amendments clarify...more

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

by Allen & Overy LLP on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

China FDA Calls for Comments on Key Policy Proposals

by Ropes & Gray LLP on

On May 11-12, 2017, the China FDA (CFDA) issued four new draft policies for public comments, proposing further reforms in the current drug and medical device regulatory regime. The four draft policies aim to accelerate the...more

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

Top Ten International Anti-Corruption Developments for January 2017

by Morrison & Foerster LLP on

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

CFDA Amends Medical Device Recall Rules

by Ropes & Gray LLP on

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim...more

GSK Settles SEC FCPA Case for $20 Million

by Michael Volkov on

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

The Oscar Meyer Wiener Theme and Revisiting GSK in China

by Thomas Fox on

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

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

by Ropes & Gray LLP on

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

by Morrison & Foerster LLP on

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

by Ropes & Gray LLP on

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

by Knobbe Martens on

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

by Ropes & Gray LLP on

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

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