The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.
The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. Once you have paid the fee, you can then complete the registration process. Your registration is not considered complete until you have
paid your annual registration user fee,
submitted your registration and listing information electronically, and
received e-mail notification from FDA that all requirements have been met.
Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).
Each owner/operator must have an account ID and password to use FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a separate account ID and password for the official correspondent.
Firms that are already registered must always use their assigned account ID and password. Never create a new FURLS account if you already have one. Creating a new account will prevent you from accessing your current registration information and delay the completion of your correct registration.
FDA US Agent (FDA Agent)
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (FDA US Agent or FDA Agent) for that establishment.
Information about a foreign establishment’s US FDA Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one US FDA Agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the US FDA Agent.
The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the US FDA Agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new FDA US Agent to satisfy the regulatory obligation.
K2A Management in Cambodia provides FDA consultancy services for manufacturers in Cambodian to register their facility and products with a smooth transaction and expert advisory services.