Establishment Registration Types
Establishment, Exporter, FDA, Foreign, Importer, Manufacturer, QSR, Specification
In 2013, recognizing the realities of how Medical Devices that are sold in the U.S. are actually developed, manufactured, distributed and supported after distribution, FDA expanded the range of types of businesses required to register with FDA as Establishments. The reality is that many companies only directly perform only part of the activities described in the FDA Quality System Regulation. Consequently, many Medical Devices are designed by one company, manufactured by another company and distributed by yet another company. For Foreign companies, Medical Devices can be also exported by yet another company, and imported by yet another company.
With the exception of Distribution, if your company does any of these activities, your company needs FDA Establishment Registration as one or more of several Establishment types. Here’s the tip:
Determine the appropriate type of Establishment for your company based on the current and near-term planned business activities.
Establishment Registration generally involves:
- Establishing an appropriate Quality System for your business
- Registering online with FDA
- Paying an annual Establishment Registration fee
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Here a description of the most common Establishment types I have encountered for U.S. companies:
Medical Device Manufacturer – Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user.
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.
Contract Manufacturer – Manufactures a finished device to another establishment’s specifications.
Contract Sterilizer – Provides a sterilization service for another establishment’s devices.
These (4) Establishment types perform activities that are described in the FDA Quality System Regulation (QSR), 21CFR820.
In addition to these, companies outside the U.S. can also be a Foreign Exporter, and export devices to the U.S. in conjunction with another Establishment type, an Initial Importer.
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 – Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
These (2) Establishment types do not perform activities that are specifically described in the FDA Quality System Regulation (QSR), 21CFR820. However, Initial Importers are subject to:
Medical Device Reporting (MDR) under 21 CFR 803.
Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and nonMDR events) must be forwarded to the manufacturer.
Reports of Corrections and Removals under 21 CFR 806.
Medical Device Tracking under 21 CFR 821, if applicable. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.
BDA and its subsidiary, Medical Device Post-Production Services (MDPPS) provide a range of services to help your company overcome Establishment Registration challenges. MDPPS is an FDA-registered Initial Importer.