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TechLink International provides services for foreign establishments seeking to import Medical Devices into the United States. Without a US Initial Importer, the FDA will not release your items for distribution and may issue an action against the manufacturer.
Initial Importers must submit reports of malfunction within 30 days to the manufactory. It is also important to note that the MDR regulations hold manufacturer responsible for investigating of each event and evaluating the cause of the event.
Therefore, foreign manufactories need to have a clear understanding of MDR regulations. Foreign manufactories should also understand how the importer intends to comply with the MDR regulations. This is critical because some overseas manufactories believe that only the US importer is directly responsible for submitting MDR reports.
The Initial Importer is also subject to 21 CFR 806 reports of Corrections and Recalls and Removals as applicable, and in some case Medical Device tracking.
International manufactures will benefit by hiring TechLink International LLC as their US Agent and Initial Importer, especially those organizations that require their US Agent to perform medical device reporting responsibilities on their behalf.
These fines are not just one-time fees but can accumulate over time, severely impacting your business's bottom line.
In the event of Safety concerns, mandatory recalls may be required.
Non-compliant products may be barred from being sold, limiting your company's growth and revenue opportunities.