Vietnam → US: Medical Devices U.S. Agent
Vietnam-based medical device establishments manufacturing or distributing devices that export to the United States are required by FDA to designate a U.S. Agent. Assurentry provides fast, reliable U.S. Agent representation for companies in Vietnam.
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Why Vietnam Companies Need a U.S. Agent
Under U.S. federal law, every foreign facility that manufactures, processes, packs, or holds medical devices for export to the United States must designate a person residing or maintaining a place of business in the U.S. as their agent.
For companies in Vietnam, this means appointing a U.S.-based representative who can receive FDA communications, assist with inspections, and act as your point of contact with the agency. Without a valid U.S. Agent, your FDA registration is incomplete and your products may be refused entry at U.S. ports.
Assurentry has extensive experience serving medical devices companies from Vietnam and throughout the southeast asia region. We understand the specific regulatory challenges your business faces and provide responsive, knowledgeable support.
What's Included for $399/year
21 CFR 807.40 — Medical Devices U.S. Agent Requirement
The FDA regulation 21 CFR 807.40 requires all foreign medical devices establishments to designate a U.S. Agent as part of their facility registration. Here is what that means for your Vietnam-based business.
Regulatory Authority
The U.S. Agent requirement is established under 21 CFR 807.40 and enforced by the U.S. Food and Drug Administration (FDA). Compliance is mandatory for all foreign facilities in the medical devices category.
Agent Responsibilities
Your U.S. Agent receives FDA communications on your behalf, assists with FDA inspections of your facility, helps respond to questions from FDA, and serves as an emergency point of contact for recalls or safety issues.
Consequences of Non-Compliance
Facilities without a valid U.S. Agent cannot complete their FDA registration. This can result in import refusals, shipment detentions at U.S. ports, FDA warning letters, and loss of market access.
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Appoint Assurentry as your U.S. Agent today for just $399 per year. We'll file the designation with FDA and provide your acceptance letter within one business day.
Trusted by 2,800+ companies in 160+ countries