In the current issue of the JMDR...

  • CERs: how to write and maintain compliant Clinical Evaluation Reports (CERs)
  • Market surveillance: the little-known market surveillance requirements of Regulation (EC) No 765/2008 and how they apply to medical devices
  • Korea: recent changes to the Republic of Korea’s medical device registration system
  • HTAs: the European collaboration on Health Technology Assessments (HTAs) of medical devices
  • Medical device and in vitro diagnostic medical device (IVD) regulatory updates in Australia, Brazil, Canada, China, Denmark, Ecuador, the European Union, Germany, Hong Kong, India, International, Ireland, Japan, Malaysia, Norway, Peru, Singapore, South Africa, Taiwan, the USA and Vietnam
  • Country overview: summary of the regulatory requirements for medical devices and IVDs in Brazil
  • Book review: Biomaterials and devices for the circulatory system