July 23, 2018 By Danielle Kirsh Australia TGA to change Prostheses List publication schedule starting in 2019
July 20, 2018 By Danielle Kirsh China FDA accepting MDCO certificates from Hong Kong-based medical device registration applicants
July 11, 2018 By Danielle Kirsh South Korea changes guidelines for medical device cybersecurity management
July 10, 2018 By Danielle Kirsh Key questions for the role of post-market surveillance in European MDR
July 9, 2018 By Danielle Kirsh MDR and IVDR publication requirements for user information on medical device manufacturer websites
June 1, 2018 By Danielle Kirsh FDA plans fast-track development and marketing program for medical devices that treat opioid addiction
May 29, 2018 By Danielle Kirsh FDA takes cautious approach to new regulations for OEM and third-party device servicers