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To import a medical device into the United States you will need a Importer of record (IOR) in addition of the FDA Agent and FDA Initial Importer.
TechLink International LLC is a full-service turnkey quality and regulatory consulting firm that covers medical devices by providing easy and simplified access to tools and information in a cost-effective manner.
An "Importer of Record" is an individual or entity responsible for ensuring that imported goods comply with all the laws and regulations of the country into which the goods are being brought. This includes:
The Importer of Record is responsible for paying any import duties, taxes, and other charges assessed by the government.
They must provide and verify all necessary documentation required for customs clearance, including invoices, packing lists, and other relevant paperwork.
They must ensure that the goods meet all the necessary standards and regulations of the importing country, such as safety, health, and environmental protections.
Maintaining records of transactions, shipments, and compliance documents is a critical responsibility to demonstrate adherence to all applicable laws.
The Importer of Record can be the owner of the goods, the purchaser, or a licensed customs broker authorized to act on behalf of the owner or purchaser. This role is crucial for the smooth processing of goods through customs and to avoid legal or regulatory issues.
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.