14 US Agent Questions to Know to Meet Medical Device Regulations Medical device regulations must be met if you want to sell your products in the United States. The following questions and answers will help you meet these requirements. 1. Are You Required to Appoint a US Agent? Yes. The FDA requires foreign […]
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FDA: 2023 Medical Device User Fees Announcement Medical device user fees for the Fiscal Year 2023 are now available following an announcement from the U.S. Food and Drug Administration (FDA). The fiscal year runs from October 1, 2022 – September 30, 2023. All medical device facilities must pay the new fee amounts to keep their
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Latest Medical Device User Fee Amendment (2022) FDA has released the new medical device user fee amendment (MDUFA) for 2022. The US Food and Drugs Administration has established a 2.5% increase in Fees charged to Medical Devices manufacturers. This fee increase includes applications for Premarket Approval, 510(k) clearance, establishment registration and other applications in
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FDA registration requirements to import Face Mask Guidelines to import face mask and FDA registration Non-surgical Face mask (no EUA required) Register as an importer, and have your manufacturer the FDA registration as a medical device manufacturing establishment with FDA. List the medical device product that you intend to import. (FDA’s fee is $5,236,
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SIs It Mandatory FDA Establishment Registration? Overview of When FDA Establishment Registration is Required FDA establishment registration varies depending on the FDA regulated product marketed and sold. Various types of FDA facility registration are discussed in the sections below. In general, prior to entering the market a company must classify the product, determine if FDA approval
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