初期輸入業者

• What is an Initial Importer defined by the FDA? ​

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​​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.

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• 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.