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INITIAL IMPORTER
INITIAL IMPORTER
  • What is an Initial Importer defined by the FDA? 

    • According to the FDA definition, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
       

  • Why do you need an Initial Importer?

    • The FDA requires a designated, US-based entity (the Initial Importer) to be legally responsible for ensuring that all imported products comply with FDA regulations like:

      • Labeling: Ensuring labels meet FDA standards.

      • Safety: Verifying product safety through documentation and, if needed, testing.

      • Adverse Events: Reporting any adverse events or product problems to the FDA.

      • Recalls: Coordinating and executing product recalls if necessary.

    • The Initial Importer also acts as the FDA's primary contact point for all regulatory matters related to the imported product. This direct communication channel simplifies:

      • Inspections: Facilitating FDA inspections of imported products.

      • Notifications: Providing updates on product changes or compliance issues.

      • Detentions: Resolving issues if a product is detained by the FDA.

    • It is governed by the Code of Federal Regulations for importers to register their facility (21 CFR 807.20) and to be identified by the manufacturers. (21 CFR 807.41)

 

  • What are the Requirements? 

    • Initial importers are required to register with the FDA and pay the annual registration fees.

    • The initial importers must have a physical address (a business that the FDA can visit and perform a site audit directly) in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.

    • Under medical device reporting regulations put forth by the FDA, the initial importers are required to report (Medical Device Reporting, Corrections, and Removal Reports...etc) incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions.

    • Through the initial importer's FDA registration, the FDA requires the importer to be accountable for reporting adverse events, recalls, customer complaints, and any other postmarket investigation activities regarding the device.

    • All medical devices imported into the United States must meet the U.S. Customs and Border Protection (CBP) and FDA regulatory requirements.

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PCG's FDA Initial Importer Services Include:

For foreign manufacturers, finding distributors registered as initial importers with the FDA is not easy because most distributors in the US do not want to manage the complicated responsibilities of the initial importer. The ideal solution would be to identify an independent company that specializes in the initial importer role. Provision Consulting Group ("PCG"), with many years of experience assisting 650+ clients worldwide to navigate and comply with complex FDA medical device regulations, provides that exact professional initial importer service for our clients overseas.
Our FDA initial importer service allows foreign manufacturers to spend more time developing their devices rather than searching for distributors and learning FDA regulations. Our clients not only save the FDA's annual initial importer registration fee by designating PCG as their initial importer, but, more importantly, they reclaim valuable time that would otherwise be spent deciphering complex FDA regulations. Time is a precious resource that money can't buy!

Now, the services PCG provides:

  • US Agent Service

    • Recognized as a US Agent on behalf of foreign companies for the FDA and act as a mediator between foreign companies and the FDA (i.e. regarding inspection notices, warning letters or import alert letters)

    • Assist in responding to questions from the FDA concerning the submissions and the products of foreign companies

    • Deemed the emergency contact with the FDA

    • Any foreign establishment engaged in the manufacturing, preparation, propagation, compounding, or processing of drugs imported into the United States must identify a “US agent” for that establishment

  • Report death, serious injury, and malfunctions as well as register, report, and archive all non-conformities, customer complaints, recalls and post-market survey activities (803.40 and 803.42)

  • Report of Corrections and Removals (806)

  • Conduct Medical Device Tracking (821), if applicable

  • Be in compliance with the FDA’s quality system requirements, including FDA’s on-site inspection (820)—the cost to cover the FDA inspection shall be billed separately at the time of the inspection

  • Conform with specific procedures envisaged in regarding the storage, keeping and handling of the devices (820)

  • Assist with customs clearance in regard to the US FDA initial importer identification

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