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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. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
Manufacturers must list their devices with the FDA. Establishments required to list their devices include:
When completing product listings for facilities, keep in mind that you are required to identify any combination products.
If you are uncertain whether a product qualifies as a device or a combination product, please contact our office at 305-206-6777 for assistance.
TechLink International LLC provides FDA medical device registration and listing services free of charge when you contract our Initial Importer or US Agent service. We have thirty years of experience; we can provide expert advice on all regulatory requirements for medical devices. Our 360 solution module will give you the support you need until you have met all the FDA medical device regulations.
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.