News & Analysis as of

Medical Devices China Pharmaceutical Industry

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

Hogan Lovells on

This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Hogan Lovells

Regulation of drug and medical device advertising in China: an industry under the microscope

Hogan Lovells on

In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the in-licensing of products to China include...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

Hogan Lovells on

The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

K&L Gates LLP

Five Things to Know About the Changes to China's Medical Device Regulation

K&L Gates LLP on

On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

Morgan Lewis on

China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

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

Seyfarth Shaw LLP

FDA Updates Emergency Use Authorization For Chinese Respirators

Seyfarth Shaw LLP on

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

Seyfarth Shaw LLP on

China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures

Hogan Lovells on

On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more

McDermott Will & Emery

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

McDermott Will & Emery on

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...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

Robins Kaplan LLP

Financial Daily Dose 1.31.2020 | Top Story: IBM CEO Ginni Rometty is Out After Eight Years at the Helm

Robins Kaplan LLP on

In a week that’s already seen plenty of C-suite shakeups, we’ve learned that Ginni Rometty is stepping down from her role as CEO at IBM. The company’s cloud computing chief, Arvind Krishna, will take over for her, though...more

Fenwick & West Life Sciences Group

Biotech & Life Sciences Trends to Consider Following JPM 2020: M&A, Venture Capital and More

The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....more

Morgan Lewis

Life Sciences International Review - Q2 2019

Morgan Lewis on

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 3 – Red Flags

I continue with the multi-part blog post series based upon the New York Times (NYT) article by Alexandra Stevenson and Sui-Lee Wee, entitled “Selling CT Scanners with Bricks of Bills in China”, which details allegations of...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 2 – The Bribery Schemes

After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more

McDermott Will & Emery

International News Life Sciences - Winter 2018

McDermott Will & Emery on

Data Inspections in China: Increased Supervision and Compliance - Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to comply. ...more

A&O Shearman

China’s new anti-bribery agency announces pharma probe

A&O Shearman on

China’s State Administration for Market Regulation (SAMR) has announced the launch of a nationwide campaign to crack down on unfair competition and commercial bribery in the pharmaceutical, medical device and educational...more

Hogan Lovells

CFDA Continues to Expand Oversea Inspection

Hogan Lovells on

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good...more

Knobbe Martens

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

Knobbe Martens on

BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The...more

45 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide