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.
China’s Food and Drug Administration received more than 350,000 medical device adverse event reports in 2016, an increase of 10 percent on the previous year. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers an update on CFDA’s clinical trial reform.Read More
The FDA is moving ahead with plans for the National Evaluation System for Health Technology (NEST) as one of its top CDRH priorities this year. Read More
International labeling rules requiring the expiration date and date of manufacture on the device label conflict with India’s labeling requirements. Read More
The FDA lacks a good mechanism for dealing with the hundreds of device accessories currently on the market which may be inappropriately classified, and a new House bill proposes to streamline the process. Read More