In the current issue of the JMDR...

  • De novo: strategies and tactics to use and avoid when using the de novo pathway in the USA
  • Standards: questioning whether the costs associated with the application of basic and general standards are proportionate to the risk of a medical device
  • 21st Century Cures Act: an analysis of the key provisions relating to medical devices in the Act's discussion draft
  • Directive 93/42/EEC: examples of inadequately defined or undefined terms and proposed interpretations
  • Medical device and IVD regulatory updates in Australia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, the European Union, Germany, India, International, Ireland, Italy, Malaysia, Mexico, Pakistan, Peru, Saudi Arabia, South Korea, Switzerland, the UK and the USA
  • Country overview: summary of the medical device regulatory requirements in Indonesia