Registered FDA Agent

According to the FDA, assigning a registered agent is required for any medical device company that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States. An FDA agent acts as the primary point of contact between the FDA and a medical device company.

At Zi-Medical, we are equipped with the expertise to help you every step of the way, no matter where you are in the process of registering your medical device. By choosing us as your FDA agent, we will:

  • Monitor your compliance with FDA standards, 
  • Assist with FDA registration and reporting, 
  • Assist the FDA in communications with your company, and 
  • Provide guidance with FDA requirements for your industry
  • Assist the FDA in scheduling inspections of your facilities  

Get quality services from industry professionals, all for one flat fee.