As communication and travel have become easier, companies that were once destined to serve only a small area can now have a global reach. With that reach comes the challenge of adhering to the regulations of multiple different regulatory authorities. One common regulation is the appointment of an agent or representative within the country that the company is trying to start selling in. In the U.S. the FDA requires a “U.S. Agent” for any foreign company who wants to sell in the U.S.[1]. In the European Union, an Authorized Representative is necessary[2].
While these two may sound similar each has its own requirements and responsibilities. The FDA states the U.S. Agent must be a person who is physically in the U.S.[3] meaning that the company cannot simply get a P.O. box in the U.S. and use that as their Agent. Similarly, the EU requires the Authorized Representative to be a person established within the EU2.
For the FDA the Agent acts more as a contact point than anything else. The FDA may ask the Agent questions about the device or request assistance setting up inspection dates1. The EU, on the other hand, has a multitude of other responsibilities for the Authorized Representative. For example, per the EU MDR 2017/745, the Authorized Representative is required to keep copies of the technical documents and other documents associated with any device being sold in the EU2.
While it may be tempting to select just anyone with an address in the country you are trying to sell it would be ill-advised. Picking someone who understands regulations and the standards involved with the device you are trying to sell is important for success overseas. In the U.S. EMMA International is capable of acting as U.S. Agent. Additionally, EMMA International can also assist with regulatory submissions to regulatory bodies around the globe, developing a quality management system, and more. For more information about EMMA International’s services visit our website at www.emmainternational.com. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
[1] FDA (December 2017) U.S. Agents Retrieved 10/19/2021 from https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents
[2] EU (April 2020) Regulation (EU) 2017/745 of the European Parliament and of the Council Retrieved 10/19/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424
[3] FDA (April 2020) Title 21 CFR 207 Retrieved on 10/19/2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=207.69
