发布时间：2014-06-18
需要进行FDA注册的医疗器械相关公司类型
Who Must Register, List and Pay the Fee
Foreign Establishments美国境外公司
|
Register |
List |
Pay Fee |
|
|
Foreign Manufacturers |
YES |
YES |
YES |
|
Foreign Exporter of devices located in a foreign country |
YES |
YES |
YES |
|
YES |
YES |
YES |
|
|
YES |
YES |
YES |
|
|
Reprocessor of Single-use Device |
YES |
YES |
YES |
|
Custom Device Manufacturers |
YES |
YES |
YES |
|
YES |
YES |
YES |
|
|
Device Being Investigated under IDE |
NO |
NO |
NO |
|
YES |
YES |
YES |
|
|
YES |
YES |
YES |
|
|
Manufacturer of components that are distributed only to a finished device manufacturer |
NO |
NO |
NO |
|
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user |
YES |
YES |
YES |
|
Maintains complaint files as required under 21 CFR 820.198 |
YES |
YES |
YES |
Domestic establishments 美国境内公司
|
Activity |
Register |
List |
Pay Fee |
|
Manufacturer |
YES |
YES |
YES |
|
Manufactures a custom device |
YES |
YES |
YES |
|
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user |
YES |
YES |
YES |
|
Manufacturer of components that are distributed only to a finished device manufacturer |
NO |
NO |
NO |
|
YES |
YES |
YES |
|
|
YES |
YES |
YES |
|
|
YES |
YES |
YES |
|
|
YES |
YES |
YES |
|
|
Domestic Distributor |
NO |
NO |
NO |
|
YES |
YES |
YES |
|
|
Specification Consultant Only |
NO |
NO |
NO |
|
YES |
NO |
YES |
|
|
Import agent, broker, and other parties who do not take first possession of a device imported into the United States |
NO |
NO |
NO |
|
Device being investigated under IDE |
NO |
NO |
NO |
|
Reprocessor of single use devices |
YES |
YES |
YES |
|
YES |
YES |
YES |
|
|
Maintains complaint files as required under 21 CFR 820.198 |
YES |
YES |
YES |
|
Establishments located in foreign trade zone |
YES |
YES |
YES |
|
Refurbishers |
NO |
NO |
NO |
FDA公司类型定义：
Definitions of Establishment Activities
Contract Manufacturer - Manufactures a finished device to another establishment's specifications.
Contract Sterilizer - Provides a sterilization service for another establishment's devices.
Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Initial Importer - Takes first title to devices imported into the U.S. An Initial Importer must have a U.S. address.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
Reprocessor of Single Use Device - Performs remanufacturing operations on a single use device.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.
U. S. manufacturer of export only devices - Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
IRC编译整理
www.FDAChina.com
