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?
-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?
- Importers are also required to register with the FDA and pay the annual registration fees (as are manufacturers).
- The initial importer must have a physical address
(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, an initial importer is 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 regulatory requirements of both the U.S Customs and Border Protection (CBP) and FDA.
Provision 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 provides professional initial importer service.
With many years of experience and dozens of clients all over the globe,
Provision Consulting Group is capable of ensuring that your business conforms to U.S Food & Drug Administration (FDA) regulations.
Not only do we serve as a regulatory requirement for foreign/domestic manufacturers, but we also assist in navigating the complexities of medical device regulations.
Our services allow manufacturers to spend more time developing their devices rather than searching for distributors, negotiating contracts, and learning regulations.
Also, our clients do not have to pay the annual registration fee to the FDA since we are already registered as an initial importer.
This is critically important to saving your company time and money.