Our services
US AGENT
The US FDA Agent Service is a mandatory regulatory requirement for foreign manufacturers of medical devices seeking to market their products in the United States.
Foreign manufacturers must enlist legal professionals possessing expertise in U.S. regulations, FDA requirements, and pertinent areas of law. This ensures compliance and facilitates the successful navigation of the legal aspects involved in entering the U.S. market.
The FDA Agent, whether an individual or organization based in the US, serves as a communication liaison between the FDA and the foreign manufacturer. Their role involves aiding the manufacturer in adhering to FDA regulations, managing communications from the FDA, and maintaining precise records of interactions. The FDA Agent plays a crucial role in ensuring that the manufacturer's products can be legally marketed and sold in the United States while complying with FDA regulations.
Amstermed as U.S. agent must resides in the U.We are available to answer the phone and have an employee available to answer the phone during normal business hours
Throughout the process, Amstermed acts as the liason between(manufacturer) and the regulatory authorities, ensuring smooth communication, adherence to regulatory requirements,and timely completion of the neccessary steps to obtain the free sale certificate.
- Assisting FDA in communications with the foreign establishment,
- Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States.
- Assisting FDA in scheduling inspections of the foreign establishment and
- If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
As your legal agent, we assist you in comprehending and adhering to the intricate regulatory standards established by the U.S. Food and Drug Administration (FDA) for medical devices. Our guidance encompasses product classification, labeling and advertising requirements, pre-market submissions, quality system regulations, post-market surveillance, and other pertinent regulations.
We help owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) to register annually with the FDA.
As your legal professionals, we aid in formulating a market entry strategy for the U.S. market. Our services involve evaluating the regulatory landscape, identifying potential entry barriers, and offering guidance on the suitable pathway for market authorization, whether it entails clearance, approval, or other regulatory processes.
We assist in negotiating and drafting contracts and agreements necessary for your operations in the United States
We provide guidance on import and customs regulations to ensure manufacturers comply with relevant laws when importing products into the United States.
We stay current with evolving U.S. regulatory requirements and offer manufacturers insights into any changes that may affect their business. Our assistance includes helping manufacturers adapt to new regulations, updating their compliance strategies, and ensuring continuous regulatory compliance.
Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for:
- Ensuring the accuracy of registration and listing information; and
- Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.
United States agent. Registrants of foreign establishments subject to this part must designate a single United States agent. The United States agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present. The United States agent is responsible for:
- Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
- Responding to questions concerning those drugs that are imported or offered for import to the United States;
- Assisting FDA in scheduling inspections; and
- If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.