Medical device firms that manufacture medical devices imported into the United States (US), including contract manufacturers and contract sterilizers, must designate a US Agent. After designating the US Agent, the device firm must notify the US Food and Drug Administration (FDA) of the name, address and phone number of their US Agent during the annual on-line registration process. In accordance with the regulations in 21 Code of Federal Regulations (CFR) 807.40, each non-US establishment may designate only one US Agent, who is either a resident of the United States or maintains a place of business in the US.
US Agent services are important because, in the event that FDA is unable to contact a company directly or expeditiously, FDA may provide information or documents to the US Agent. This action is considered to be equivalent to providing the same information or documents to the company.
Therefore, medical device companies seeking US Agent services should designate only those companies that are qualified to offer these services and that can represent the company's regulatory interests in an appropriate manner. GEMAR meets this requirement.
  • We have more than 25 years of experience in communicating with the FDA.

  • We understand the challenges for foreign companies, due to our expertise on different country regulations and extensive experience in assisting non-US device manufacturers.

  • If needed, we can provide clarifications on FDA inquiries and assist your firm in providing effective responses to FDA questions on your products.

  • We can help you to prepare for FDA inspections 

As your US Agent, GEMAR will be responsible for:
  • Assisting FDA in communications with your company

  • Responding to questions concerning your products that are exported or offered for export to the US, and

  • Assisting FDA in scheduling inspections of your company

GEMAR is ready to assist you with registration and listing, and can answer any questions that you may have - contact us for further information.
FDA does not require the U.S. Agent to report adverse events under the Medical Device Reporting regulation (21 CFR Par 803) for your firm or submit 510(k) Premarket Notifications. 
  • As the designated US Agent, we can also serve as FDA Official Correspondent for registration of your foreign establishment.

  • If you manufacture devices that emit electronic radiation, we may also act as your “manufacturer’s agent”.

  • We can serve as an “authorized representative” for a Premarket Approval Application.

  • We can assist you in reporting adverse events under the Medical Device Reporting regulation (21 CFR Par 803). 

Feel free to contact us and see how we can assist you.