In the current issue of the JMDR...

  • USA: The US Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP)
     
  • EU: From the Directives’ Essential Requirements to the new Regulation’s General Safety and Performance Requirements (GSPRs): revolution or evolution in the regulation of medical devices in the European Union?
     
  • ASEAN: Current status of the ASEAN Medical Device Directive (MDD)
     
  • Thailand: An overview of the medical device regulatory requirements in Thailand
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Argentina, Australia, Brazil, Canada, China, Czech Republic, Ecuador, European Union, Finland, France, Germany, Honduras, Hong Kong, India, Japan, Korea (Republic of), Malaysia, Mexico, Philippines, Portugal, Saudi Arabia, Singapore, Switzerland, Taiwan, Uganda, the UK, the USA and Vietnam
     


 

In the previous issue of the JMDR...

  • Australia: Reforming Australia's regulations - doing more with less Down Under
     
  • Product prioritisation: Adopting a strategy to identify products with the highest commercial value for certification under the new EU Regulations
     
  • Digital health: Is digital health an opportunity or a challenge?
     
  • Chile: An overview of the medical device regulations in Chile
     
  • Medical device and in vitro diagnostic medical device (IVD) regulatory news updates in Australia, Brazil, Canada, China, European Union, Hong Kong, India, Israel, Malaysia, New Zealand, Peru, Saudi Arabia, Serbia, Singapore, Spain, the UK, and the USA