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:
- Establishment must be registered with the FDA
- 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.
- Responsible for registering, reporting, and archiving all non-conformities, customer complaints, recalls and all post-market survey activities.
- Responsible for Medical Device Tracking of certain devices through the supply chain.
- Official FDA documentation on Initial Importer: FDA LINK
- Assisting FDA in communications with the foreign establishment.
- Responding to questions concerning the foreign establishments devices that are imported or offered for import into the United States.
- Assisting FDA in scheduling inspections of the foreign establishment.
- If the 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.
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
Distribution networks are crucial for a profitable medical device company, therefore, we have tailored our services to help you find the best distributors for your needs by:
- Finding qualified distributors for your device’s field, or expertise.
- Maintaining a strong, mutually beneficial relationship.
- Negotiating contracts.
- Constantly looking for new, qualified distributors.
- Provide training and continuous follow ups with distributors.
- Act as as key contact for the distributor in the United States.
- Analyze target consumer
- Analyze current market in country of choice (CA, USA, South America).
- Analyzing current market size.
- Establishing a forecast based on previous sales.