We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics. Read More
U.S. industry group AdvaMed is working with regulators around the world to ensure a global approach to unique device identification — to avoid scenarios where different countries’ UDI systems can’t communicate with one another.
Read More
The FDA’s Neurological Devices Panel will meet April 17 to discuss clinical trial considerations for flow diverters that are intended to treat brain aneurysms. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
China’s medical device authority released a draft regulation outlining how it will accredit medical institutions that conduct clinical trials for devices. Read More