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A brief overview of regulatory framework for medical devices in India
  • Singh & Associates
  • India
  • September 29 2012

India has emerged as one of the leading markets for pharmaceutical products.

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

Do the new medical device registration requirements really apply to me?
  • Arnall Golden Gregory LLP
  • USA
  • January 9 2013

FDA has changed certain medical device establishment registration and listing requirements in accordance with the Medical Device User Fee Amendments

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

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

A structured guide to clinical trials in the USA

Obligation to indemnify executive accused of criminal conduct
  • Dorsey & Whitney LLP
  • USA
  • June 27 2012

I am the general counsel of a corporation in the medical device industry.

Mary Carter and other agreements should be disclosed to juries
  • Epstein Becker Green
  • USA
  • March 27 2013

As a general proposition, a defendant at trial suffers unfair prejudice when the court does not permit the jury to learn of certain facts that, if

New requirement of a responsible person for medical device manufacturers
  • PDG Avocats
  • European Union
  • January 29 2015

On 26 September 2012, the European Commission adopted two proposals for a Regulation (one on medical devices and in parallel one for a Regulation on

Biotechnology leasing special issues in leasing laboratory space
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • June 9 2010

Biotechnology laboratory facility leases present unique commercial leasing issues that landlords and tenants should anticipate if they are to achieve successful leases.