Branded US Office Establishment Service

Foreign manufacturers seeking to establish a more local presence in the US market should consider opening a Branded Office in the US to provide an enhanced image to prospective clients and customers. Americas Actual can assist manufacturers with setting up a local franchise in Texas, which requires no annual fees or tax burdens, only the annual filing of paperwork.

Branded Office Established charged as a flat setup fee.

Outsourced Office Management

Americas Actual will then manage the branded office, handling all annual regulatory and financial responsibilities. While technically owned by Americas Actual, the entity can be transferred to the manufacturer at any time upon request.

Office Management charged as an Annual Fee.

FDA Establishment Registration and Product Listing

All owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the US are required to register annually with the FDA. This process is known as establishment registration. Americas Actual will manage the payment, registration and listing process on your behalf.

FDA Establishment Fee: $5,236

Act as Your Own FDA US Agent

Foreign manufacturers must identify a US Agent to manage communication with the FDA and be listed on their Establishment Registration form. Under a branded office, Americas Actual will manage the entity as your US Agent, maintaining a place of business in the US (PO boxes not permitted) and remaining available to answer the phone during normal business hours. Activities also include answering questions from the FDA on imported devices or assisting in scheduling inspections.

Act as Your Own Initial Importer

Manufacturers with their own office can also act as their Initial Importer which can also be managed by Americas Actual, allowing your products to remain under your brand throughout the entire process. Initial Importers are subject to FDA inspections and responsible for reporting adverse events to the FDA.

Activities performed as the Initial Importer:

• Facilitate the marketing of your Class I and/or Class II devices from export to the person who makes final delivery or sale;

• Report adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking (if applicable);

• Maintain an MDR event file for each adverse event.

Initial Importer Management charged as an annual fee.