September 17, 2019 By Danielle Kirsh Saudi Arabia regulators plan new MDMA fees, risk classification system for medical device registrants
September 16, 2019 By Danielle Kirsh Mexico medical device import permit application process goes fully online
September 12, 2019 By Danielle Kirsh Chinese regulators publish UDI system rules for medical device registrants
September 11, 2019 By Danielle Kirsh FDA requires more clarity on informed consent forms for clinical trials
September 9, 2019 By Danielle Kirsh Examining common medical device cybersecurity approaches in the U.S., Canada and Australia
September 3, 2019 By Danielle Kirsh How medical device early-use research and testing affects product design and development
August 30, 2019 By Danielle Kirsh IMDRF publishes Conformity Assessment Body recognition requirements
August 29, 2019 By Danielle Kirsh FDA finalizes post-market safety reporting guidance for combination products
August 26, 2019 By Danielle Kirsh FDA adds AAMI/UL 2800 standards for medical device interoperability
August 20, 2019 By Danielle Kirsh DEKRA receives Notified Body designation for EU Medical Devices Regulation
August 8, 2019 By Danielle Kirsh Australian TGA issues final guidance on medical device and IVD cybersecurity