Mar 24 - 6:30
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission composed of representatives of all member states, issued a guidance document dedicated to the Implant Card (IC) to advise the...
Mar 13 - 4:01
The Food and Drug Administration, the US authority responsible for medical device regulation, issued guidance dedicated to the Third Party (3P510k) Review Program allowing recognized third parties to perform the review...
Mar 12 - 4:35
The US Food and Drug Administration (FDA), the authority responsible for medical devices regulation, issued guidance dedicated to 510(k) premarket notification submissions for Electrosurgical devices for general...
Mar 11 - 4:55
Argentina informs about more upcoming changes in their medical device registration procedures. The appropriate amendments would be implemented in two consecutive steps: on March 6, 2020, and on March 16, 2020,...
Mar 10 - 3:51
All information submitted to the Mexican medical device regulating authority should be provided in the particular form set forth in the appropriate submissions guidance. The authority provides an exhaustive list of...
