The regulation of medical devices across the world is very varied, ranging from comprehensive to none.
Here in USA : Design Control – States that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met..
my question is, are the Design Controls used in the other countries ? (do web research)

For example:
United Arab Emirates (UAE):
Classification requirements and the evaluation of Devices follow international regulations and
guidelines, mainly those of:
– the IMDRF for Medical Devices,
– the US Food and Drug Administration’s Devices Regulation… so, in UAE you have to do design controls when making a medical device.( http://dgra.de/media/pdf/studium/masterthesis/master_samadi_f.pdf)
Also, Dr.Simon mentioned in the class that Design Controls are not “needed” in the EU (http://medicaldevicecourses.com/forums/topic/discussion-topic-supplemental-on-dhf-and-dmr/)