In the current issue of the JMDR...

  • Japan: Impact of recent changes to Japan's medical device regulations: a Competent Authority perspective
     
  • Biological evaluation: US FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top 10 changes affecting medical device manufacturers
     
  • Dominican Republic: Addressing the challenges of medical device registration in the Dominican Republic - requirements, trademarks, samples and timeframes: a Competent Authority perspective
     
  • LDTs: The need for increased US FDA oversight of laboratory-developed and other laboratory tests
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Argentina, Australia, Brazil, Canada, China, Colombia, the European Union, France, Korea, Malaysia, Myanmar, Russia, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, the UK and the USA
     
  • Country overview: summary of the regulatory requirements for medical devices in the Republic of Panama (written by the Competent Authority)
     

In the previous issue of the JMDR...

  • Australia: the Government's response and industry's reaction to the medicines and medical devices regulation review in Australia
     
  • 3D printing: a summary of the US FDA's proposed draft guidance on additive manufacturing and 3D printing, plus industry's perspectives on the draft guidance
     
  • UDI: the important lessons for Europe from the USA's implementation of UDI, and the benefits of prompt compliance
     
  • China RoHS: a practical look at the key updates introduced by China's Restriction of Hazardous Substances (RoHS) Regulation 2.0 in 2016
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Colombia, Egypt, the European Union, Germany, India, International, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, and the USA
     
  • Country overview: summary of the regulatory requirements for medical devices and IVDs in Kenya
     
  • Book review: Handbook of Cardiac Anatomy, Physiology and Devices, Third Edition