USA Market
US Agent Services
Medical Device
IVD
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What is US Agent Services?
US Agent services are provided to foreign medical device and drug companies that intend to market their products in the United States. The US Food and Drug Administration (FDA) requires foreign manufacturers to designate a US Agent, who serves as a liaison between the FDA and the foreign company. This service is essential for ensuring regulatory compliance, facilitating communication with the FDA, and enabling foreign companies to navigate the complexities of the US regulatory system.
Why is US Agent Services important?
The FDA requires a designated US Agent for foreign companies, and non-compliance can lead to regulatory issues and market access challenges.
US Agent Service is important for following reasons:
- Regulatory Compliance
- Communication with the FDA
- Timely Responses
- Market Access
- Emergency Response
Process Flow for US Agent Services
Selection of US Agent
Agreement and Contract
FDA Registration and Listing
Communication Channel Establishment
Regulatory Compliance Support
Submission of FDA Documents
Adverse Event Reporting
FDA Inspections and Audits
Annual Registration Renewal
Post Market Surveillance
Quality System Compliance
How can we help in US Agent Services?
The CliniExperts’ professionals will:
Facilitate communication with the FDA, ensuring that the foreign company understands and complies with US regulations and requirements.
Ensure that foreign manufacturers can respond promptly to FDA inquiries, inspections, and regulatory changes.
Help foreign companies navigate the US regulatory system, which is crucial for gaining access to one of the world's largest and most lucrative markets for medical devices and drugs.
In case of safety issues or recalls, we play a vital role in coordinating responses and ensuring compliance with FDA requirements.
Regulatory requirements for US Agent Services
Documents
The appointment of a US Agent primarily involves documentation related to the establishment registration process. Manufacturers must provide information about their US Agent, including contact details, during the establishment registration. Additionally, the US Agent may assist with the preparation and submission of various regulatory documents and communications with the FDA on behalf of the manufacturer.
Timeline
The timeline for specific activities, such as handling FDA communications and supporting regulatory compliance, can vary based on the nature and complexity of the manufacturer’s products and the regulatory interactions required.
Regulatory Body
The U.S. Food and Drug Administration (FDA) is the regulatory body responsible for overseeing medical devices in the United States. While the FDA does not officially regulate or endorse US Agent service providers, they do require foreign manufacturers to designate a US Agent when registering their establishments and to provide accurate contact information for the US Agent. The US Agent serves as a point of contact for the FDA and helps facilitate communication between the FDA and the foreign manufacturer.
Fees
The fees associated with US Agent Services can vary depending on the consulting firm or individual acting as the US Agent, the scope of services provided, and the complexity of the client’s needs.
Validity
The validity of US Agent Services is typically ongoing and can continue as long as the foreign manufacturer intends to market their medical device(s) in the United States.
