WHO : MEDICAL DEVICE REGULATIONS Global overview and guiding principles

 http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf
http://enzo-umpierrez.blogspot.com.ar/


The regulation of medical devices is a vast and rapidly evolving field that is often
complicated by legal technicalities. For example, legal terms and their meanings are
sometimes non-uniform even within one regulatory system. In an attempt to make this
complex subject easier to grasp, this Guide presents a common framework that integrates
the regulatory systems of the five countries or regions with the most advanced medical
device regulations. Non-technical language, graphics, tables and memory anchors are
used to present an overview of medical device safety issues and regulatory philosophy.