Updated: 4/15/2024
Introduction
Provision Consulting Group ("PCG") ensures compliance with the US Food and Drug Administration ("FDA") regulations through many years of experience in the FDA consulting industry for your business.
PCG's Initial Importer service offers a seamless gateway to the U.S. market for foreign companies, both small and large, seeking to expand without a prior U.S. presence. We provide budget-friendly, FDA-compliant solutions that ensure hassle-free market entry, helping through customs clearance and post-market surveillance.
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?
Companies bringing FDA-regulated devices into the US need an FDA initial importer because the FDA requires a US-based entity to be directly accountable for ensuring imported devices comply with regulations. The initial importer handles labeling, product safety, adverse event reporting, recall coordination, and is the FDA's primary point of contact (a bit different from a US Agent, which we won't get to in this article). The initial importer streamlines communication, and allows the FDA to quickly take action in the case of non-compliance, and ultimately protects US consumers and businesses from unsafe or non-compliant devices.
What are the requirements for being an initial importer?
The primary responsibility of the initial importer is as follows:
1. Initial importer is required to register with the FDA and pay the annual registration fees (as are manufacturers).
2. The initial importer must have a physical address (business that the FDA can visit and perform a site audit directly) in the U.S. and be staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
3. Under the FDA's medical device reporting regulations, the 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.
4. The initial importer is accountable for reporting adverse events, recalls, customer complaints, and any other postmarket investigation activities regarding the device.
5. The initial importer must work with and assist the U.S. Customs and Border Protection (CBP) to make sure devices are in good FDA regulatory standings.
What can PCG do for you?
Many foreign manufacturers struggle to find US distributors willing to take on the complex responsibilities of an initial importer. The ideal solution is partnering with an independent, specialized initial importer like PCG. With our extensive experience in the FDA regulations and working with global clients, we ensure your business has the qualified initial importer, but also provides FDA regulations consulting, removing the burden of regulatory compliance. This allows you to focus on what you do best – device sales and development – rather than navigating complex FDA regulations. Plus, by choosing us as your initial importer, you eliminate the hassle and expense of the FDA's annual registration fees, saving you both time and money.
Let Provision Consulting Group be your partner.
We are here to help your business GROW & EXPAND!