FDA
Regulatory
Affairs
As medical supplier consultants, we collaborate with medical device manufacturers to help them make better decisions, convert these decisions to actions and then implement these actions efficiently. Our services allow manufacturers to spend more time developing their devices rather than searching for distributors, negotiating contracts, and learning regulations.
FDA US Agent
Foreign establishments who import or offer for import into the United States must identify an FDA U.S. Agent during the registration process. The FDA U.S. Agent must be physically located in the United States and will serve as the primary and/or default point of contact between FDA and the firm.
RAF Solutions USA is registered with the FDA and Customs to represent you as your U.S. Agent.
The responsibilities of the FDA U.S. Agent are defined in 21 CFR 207.69 as:
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Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications
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Responding to questions concerning those drugs that are imported or offered for import to the United States.
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Assisting FDA in scheduling inspections
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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.
Initial Importer
An initial importer is the entity who guarantees that the products or services imported meet regulatory requirements, ensuring a facilitated import process of products. These requirements include, but are not limited to:
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Establishment must be registered with the FDA
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Establishment must have a physical address in the United States, as well as a staffed by responsible individuals to ensure the compliance of all FDA laws and regulations.
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Responsible for registering, reporting, and archiving all non-conformities, customer complaints, recalls and all post-market survey activities.
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Responsible for Medical Device Tracking of certain devices through the supply chain.