MoCRA introduced an expanded set of obligations for the Responsible Person, including requirements tied to the December 2024 deadline —now already in the past. As these obligations shift from upcoming to overdue, understanding what must now be fully implemented is essential for maintaining compliance. Continue reading to review the key responsibilities and their current regulatory implications.

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With the 2024 deadline now behind the industry, MoCRA’s facility requirements have shifted from preparation to full enforcement, placing manufacturers and processors under tighter regulatory expectations. Understanding what the FDA now requires is essential for maintaining compliance and avoiding operational setbacks. Keep reading to see the obligations that must already be in place.

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Complying with FDA deadlines is essential for any manufacturer or importer seeking access to the U.S. medical device market. Registration and listing are not one-time tasks but recurring obligations with fixed timelines. Failure to meet them can lead to import detentions and other serious consequences and in this article, we break down what you need to know.

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For newcomers, understanding the basics of registration, listing, and the role of key players like the Initial Importer and U.S. Agent is essential. This guide breaks down the process in simple terms to help you build a strong foundation for regulatory success.

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Entering the U.S. market for medical devices offers significant growth opportunities —but it also brings complex regulations. From simple thermometers to advanced infusion pumps, every product that meets the FDA’s definition of a medical device must comply with registration and listing requirements.

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A US Agent for FDA compliance is a person or entity based in the United States designated by a foreign manufacturer to act as its local liaison with the Food and Drug Administration...

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Modern medical devices and certain cosmetic “devices” such as RF skin-tightening tools often rely on Bluetooth, Wi-Fi, or cellular connectivity. While the FDA safeguards their safety and efficacy, the Federal Communications Commission (FCC) governs radio frequency (RF) emissions and spectrum use.

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