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A Quick Primer on Medical Device Registration

Are you looking to register medical devices? If so, there are certain steps you should take to ensure the most straightforward and error-free process. To help you get started, this handy guide may provide some useful information.

For starters, you should start by identifying which product class your medical device belongs to: Class one, two, or three. In the case of class two or three, you may need to submit a premarket notification or obtain premarket approval, respectively.

If your establishment is located in the United States, you’ll need to designate an official correspondent. However, if you are established outside the United States, you’ll have to designate a U.S. agent. Regardless of whether you’re domestic or international, you’ll then need to register your establishment, list products, and prepare the label (including UDI),. Medical devices must renew their registration annually.

A&L Registration is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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