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CE marking 101 frequently asked questions about CE marking (or questions that ought to be asked more frequently)
  • Morrison & Foerster LLP
  • European Union
  • August 23 2011

Despite the fact that the CE mark has been around for more than 15 years, its meaning and importance are often not well understood by those who wish to market their products in Europe, as well as the consumers and end users of such products


Meet SAHPRA - New Regulator of Medices, Medical Devices and IVDs
  • Fasken
  • South Africa
  • February 29 2016

On 24 December 2015 the Medicines and Related Substances Amendment Act, 14 of 2015 was passed into law. We refer to this as 'the 2015 Amendment'. The


Life Sciences: product regulation and liability in France
  • Reed Smith LLP
  • France, Global
  • May 29 2018

A structured guide to product regulation and liability laws in France


Clinical trials in Romania
  • Maravela & Asociații
  • Romania, Global
  • May 16 2018

A structured guide to clinical trials in Romania


Forcing Exclusivity on Your Customers May Not Be the Best Competitive Response
  • Baker & Hostetler LLP
  • USA
  • May 3 2016

In the words of the director of the Federal Trade Commission's (FTC's) Bureau of Competition, the recent enforcement against Invibio, Inc., the first


Getting ready for the EU MDR: Classification of medical devices
  • Allen & Overy LLP
  • European Union
  • March 27 2018

In this second post of our “Getting ready for the MDR” series, we look at how the MDR will affect manufacturers in classifying their devices according


Healthcare goes digital but regulation hard to disrupt
  • Baker McKenzie
  • USA, Global
  • October 28 2017

Healthcare technology is at a pivotal moment in its development. The healthcare industry is primed to take advantage of the innovative tools that


Clinical trials in the USA
  • Perkins Coie LLP
  • USA, Global
  • October 11 2017

A structured guide to clinical trials in the USA


Life sciences: product regulation and liability in Japan
  • YUASA and HARA
  • Global, Japan
  • March 14 2018

A structured guide to product regulation and liability laws in Japan


New Guidance Released on Class B, C, and D Medical Devices in Vietnam
  • Tilleke & Gibbins
  • Vietnam
  • December 22 2017

Vietnam's Ministry of Health (MOH) has recently issued a very important notification and new regulations relating to the implementation of Decree No