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In a recent announcement, the Food and Drug Administration (FDA) has identified a broad list of Class II medical devices that, when finalized, will be exempted from premarket notification requirements, subject to certain limitations per se.
Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea