Medical Device Listing post registration should be completed by owners or operators of facilities engaged in manufacturing and distribution of medical equipment/devices intended for use in the U.S.A are generally obliged to register with the FDA annually.
Establishment Registration & Device Listing with FDA
In most cases, establishments required to register with the FDA must also list the devices they manufacture and the activities they perform on those devices. If a device requires pre market approval before being marketed in the United States, the owner/operator should also provide the FDA pre-market approval number.
The location of medical device establishments and the devices manufactured at those establishments are provided to the FDA through registration and listing. Knowing where devices are manufactured improves the country’s preparedness to respond to public health crises.
U.S.Agent for Medical Device Listing & FDA Registration
All non-US manufacturers must designate a United States agent (US agent) for any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the US.
More Information about US Agent, refer FDA website
FDA Registration Fees
| Annual US Agent Fees | $449 |
| Device Listing (One time) |
$100 |
|
FDA FY 23, Fees |
$6493 |
FDA Registration and Medical Device Listing Timeline
|
US Agent Appointment & PIN Generation |
1 working day |
| FDA Fees payment and receipt of PCN (Payment Confirmation Note) | 2 working days |
| Device Listing and registration completion |
1 working day |
FDA Registration Form and Fee Payment
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