The U.S. Food and Drug Administration (FDA) requires food, medical device, drug, and radiation-emitting device companies located outside of the United States to designate a U.S. Agent when registering with FDA. FDA sends communications to your U.S. Agent regarding inspections and other regulatory matters, which often require an immediate response.
As your U.S. Agent, ZiMedical will assist with FDA registration and reporting, provide guidance with FDA requirements for your industry, assist with FDA detentions, help to monitor your facility's FDA compliance, and more. To designate ZiMedical as your U.S. Agent, simply complete the form below.
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