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.
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
IBSA Farmaceutici did not open a corrective action, as required, for a trend in adverse events involving pain and/or swelling in the knee following injection of Sinovial or other sodium hyaluronate devices, according to a Form 483. Read More
Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues. Read More
Over the next four years, the U.S. Food and Drug Administration plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The U.S. Food and Drug Administration and Customs and Border Protection are accepting applications for an 18-month pilot of a “trusted trader” program. The initiative aims to reduce inspections and oversight of products imported from manufacturers that establish tough internal import control programs of their own. Read More
Health Canada has published its 2014 list recognized medical device standards, adding 15 new standards and 10 new editions of currently recognized standards Read More