In the current issue of the JMDR...

  • USA: Can the US FDA be brought 'back to the future'?
     
  • Europe: The challenges in implementing the new European medical device and IVD Regulations
     
  • Europe: The HPRA in Ireland presents its perspective on the new European medical device and in vitro diagnostic legislation with practical advice for manufacturers and Notified Bodies
     
  • Economic Operators: A discussion of the Economic Operators in the new European Regulations on medical devices and in vitro diagnostics
     
  • India: Highlights of India's Medical Devices Rules, 2017
     
  • Ecuador: An overview of the laws and regulations for medical devices in Ecuador
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Argentina, Australia, Brazil, China, the EAEU, Egypt, the European Union, Hong Kong, India, Ireland, Japan, Kazakhstan, Kenya, Korea, Malaysia, Netherlands, Norway, Peru, Philippines, Saudi Arabia, Singapore, Taiwan, Turkey, the UK, and the USA
     

In the previous issue of the JMDR...

  • MEDDEV 2.7/1: A critical examination of the fourth revision of MEDDEV 2.7/1, the European guideline on clinical evaluations
     
  • DEHP: The regulation of DEHP in medical devices: continued use or restrictions?
     
  • Adaptive design: Reducing uncertainty in medical device development: How the US FDA's guidance on adaptive design for clinical studies can help
     
  • Reprocessing: How will the new EU Medical Devices Regulation affect the reprocessing of single-use devices
     
  • Taiwan: an overview of the laws and regulations for medical devices in Taiwan
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Colombia, Ecuador, the European Union, Finland, France, India, Ireland, Japan, Korea, Malaysia, Saudi Arabia, South Africa, Switzerland, Taiwan, the UK, the USA and Vietnam