Registration & Listing | 合法醫療器材資訊網

This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA. Note: Registration of a device establishment, ... Read More

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Points of Contact for Questions Regarding Registration and Listing for Human and Animal Drugs and Biologics ... in Electronic Format -Drug Establishment Registration and Drug Listing (PDF - 776 KB) ... 1-888-INFO-FDA (1-888-463-​6332) Read More

2017年12月23日 — Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment ... Read More

2021年3月22日 — Owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for ... Read More

2020年8月30日 — Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA ... Read More

2018年8月23日 — The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or ... Read More

註冊(Registration)與列名(Listing). 註冊與列名是美國FDA用來建立醫療器材業者管理檔案的機制，根據FD&C Act 第510節明確規定，醫療器材的製造 ... Read More