The International Device & Diagnostics Monitor (IDDM) helps devicemakers stay on top of regulatory developments in the U.S and around the world. This website tracks relevant topics — FDA and EU medical device regulations, joint inspections, UDI implementation, regulatory harmonization, conformity assessments and more — in the markets where you need to stay compliant.
IDDM tracks long-established regulatory leaders (the U.S., EU, Canada, Japan and Australia), as well as important, fast-growing markets (Brazil, Russia, India, China) and smaller ones that are gradually strengthening their regulatory structure (Middle East, Africa and Southeast Asia).
You’ll find summaries of regulatory changes, analysis of how they affect you and links to official texts of established and proposed regulations and guidelines.
Please note that this product is the combination of FDAnews’ Devices & Diagnostics Letter (DD&L) and the International Medical Device Regulatory Monitor (IMDRM). You may at times see references to those products in some of the archived stories, so don’t be alarmed.
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