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Clarifying US Medical Device Registration and Listing Requirements

mask manufacturer registration

Do you manufacture, distribute, or import medical devices for sale in the US (even if for eventual export)?

If so, you likely need to register your establishment with the FDA. This applies to both domestic and foreign companies involved in the US medical device market. There's an annual registration process outlined in Title 21 CFR Part 807.


What about listing your devices?

Most establishments that register will also need to list the specific medical devices they handle and the activities performed on those devices at their facility.


The included charts break it down further:

These charts categorize the registration and listing requirements based on the specific activities your establishment performs. They'll also clarify which activities require an annual registration fee.


Domestic Establishments

Activity

Register

List

Fee

Contract Manufacturer (including packagers)

YES

YES

YES

Contract Sterilizer

YES

YES

YES

Device under Investigation (IDE)

NO

NO

NO

Initial Importer

YES

NO

Identify manufacturer

Maintains Complaint Files

YES

N/A

YES

Manufacturer (all types)

YES

YES

YES

Refurbisher/Remarketer (Used Devices)

NO

NO

NO

Relabeler/Repackager

YES

YES

YES

Remanufacturer

YES

YES

YES

Reprocessor (Single-Use Devices)

YES

YES

YES

Specification Consultant Only

NO

NO

NO

Specification Developer

YES

YES

YES

U.S. Manufacturer (Export Only)

YES

YES

YES

Wholesale Distributor (not manufacturer/importer)

NO

NO

NO


Foreign Establishments

Activity

Register

List

Fee

Contract Manufacturer (including packagers)

YES

YES

YES

Contract Sterilizer

YES

YES

YES

Custom Device Manufacturer

YES

YES

YES

Device under Investigation (IDE)

NO

NO

NO

Foreign Exporter

YES

YES

YES

Foreign Manufacturer (including Kit Assemblers)

YES

YES

YES

Maintains Complaint Files (US Distributor)

YES

N/A

YES

Manufacturer of Accessories/Components (End User)

YES

YES

YES

Remanufacturer

YES

YES

YES

Reprocessor (Single-Use Devices)

YES

YES

YES

Specification Developer

YES

N/A

YES

Note:

  • "N/A" applies when listing is not required.

  • "Identify manufacturer" means providing the FDA with the manufacturer details for imported devices.


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