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Results: 1-10 of 27

Mobile health apps: are they a regulated medical device?
  • White & Case LLP
  • European Union
  • August 12 2015

With the proliferation of smartphones, the market for mobile applications (apps) has developed very rapidly in recent years, becoming a key driver of


China amends Regulations on Supervision and Management of Medical Devices; prior marketing approval requirement to import medical devices remains unchanged
  • White & Case LLP
  • China
  • May 2 2014

On March 31, 2014, China Premier Mr.Li Kequiang signed Decree No. 650 on the amended Regulations on Supervision and Management of Medical Devices


Parliament amends Commission’s proposal on medical devices
  • White & Case LLP
  • European Union
  • November 12 2013

On 22 October 2013, the European Parliament ("Parliament") adopted amendments to the Commission's proposal for a Regulation on medical devices


Securing patent value for Israeli medical technology companies
  • White & Case LLP
  • Israel
  • August 7 2013

Israel is a leader in medical technology and life sciences innovation. Though the life sciences industry in Israel is young, it is growing fast: in


China renames regulatory agency: what’s in store for the cosmetics and medical device industries?
  • White & Case LLP
  • China
  • June 5 2013

In March 2013, the National People's Congress of China formally changed the name of the State Food and Drug Administration (SFDA) to the China Food


FDA posts recommendations for expediting imports of medical devices
  • White & Case LLP
  • USA
  • May 16 2011

On 24 March 2011, the FDA posted on its website certain recommendations to the medical devices industry for the purpose of expediting the admissibility process of imported medical devices into the United States


Spectranetics settles with DOJ over illegally imported medical devices
  • White & Case LLP
  • USA
  • February 2 2010

On December 30, 2009, the US Department of Justice (DOJ) announced a settlement with medical laser manufacturer, Spectranetics Corp. (Spectranetics), over allegations that the company illegally imported and sold medical devices for patient use that had not been approved by the FDA


An important reminder of the value of DOJ FCPA opinion procedure as FCPA enforcement efforts continue to rise
  • White & Case LLP
  • USA
  • August 14 2009

On August 3, 2009, the US Department of Justice ("DOJ") issued its first official Foreign Corrupt Practices Act ("FCPA") guidance in more than a year


DOJ and SEC officials discuss emerging trends in FCPA enforcement; Supreme Court leaves expansive coverage decision intact
  • White & Case LLP
  • USA
  • October 21 2008

Two recent developments highlight the broad reach of the U.S. Foreign Corrupt Practices Act (“FCPA”


US medical device company agrees to pay fine and engage independent corporate monitor
  • White & Case LLP
  • USA
  • June 5 2008

AGA Medical Corporation, a US medical device company, has agreed to pay a $2 million criminal fine in connection with corrupt payments to Chinese doctors from 1997 through 2005