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.
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 premarket 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.
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
|Annual US Agent Fees||26500.00 +GST|
|Device Listing (One time)||
Guidance, DUNS Validation, Device Code review and Consultation
|Starts from 40000.00 +GST|
US Agent Appointment & PIN Generation
|1 working day|
|FDA Fees payment and receipt of PCN(Payment Confirmation Note)||2 working days|
|Listing and registration completion||
1 working day
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