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We manage import processes including Establishment Registrations, Product Listings, FDA Agent and Initial Importer representation.
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 devices for distribution and may issue an action against the manufacturer.
Generally speaking, the US Agent is a legal entity or a person in a position to communicate efficiently with the FDA and comply with the legal obligations that must be executed from the US territory. Resposibilities of the US Agent: The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address.
Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically. All registration information must be verified annually between October 1st and December 31st of each year.
Modernization of Cosmetics Regulation Act provides new authorities to FDA including:
Records Access: If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records.
Mandatory Recall Authority: If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States information to FDA within 15 business days.
Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years.
Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Responsible person: means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.
In addition to the Responsible person foreign manufactories must designate a US Agent.
The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address.
The responsibilities of the U.S. Agent are limited and include:
Please note that the U.S. Agent has no responsibility related to reporting of adverse events.
Medical devices that use radio frequency (RF) energy for medical purposes require equipment authorization from the Federal Communications Commission (FCC). The FCC's Office of Engineering and Technology (OET) is responsible for authorizing these devices.
The US Agent must be based in the United States and be authorized to receive legal notifications and other official documents on behalf of the manufacturer or importer. The US Agent is a significant step towards ensuring the security and reliability of the communications supply chain in the United States.
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.
