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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
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More
Citing problems faced by stakeholders, Malaysia’s Medical Device Authority has issued a series of policy notices aimed at helping industry comply with the 2012 Medical Device Act. Read More
Medtech companies are under no obligation to correct misleading third-party statements or claims about their products made on social media, websites and online forums — even if the website is owned by the manufacturer. That’s the bottom line in a U.S. Food and Drug Administration draft guidance released June 17. Read More