U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers
ALL FOREIGN PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS MUST BE
REGISTERED WITH THE FDA AND DESIGNATED A U.S. AGENT BY FEBRUARY 11, 2002
WHY ARE U.S. AGENTS REQUIRED?
The FDA has given final approval to the regulatory requirement that
all Foreign Establishments whose products (Human Drugs, Animal Drugs,
Biological Products, and Devices) are imported or offered for import
into the United States must identify a United States Agent. The U.S.
agent plays the role of the domestic representative for the foreign
facility through which all communication with the FDA takes place.
WHAT IS THE DEFINITION OF A FOREIGN FACILITY?
The final rule states that all foreign establishments who
manufacturer any of the following:
- Medical device manufacturers
- Human drug manufacturers
- Animal drug manufacturers
- Biological manufacturers
must have a designated agent in the USA by February 11, 2002.
AS YOUR U.S. AGENT, WHAT WILL mdi DO?
Based on the responsibilities outlined by the U.S. FDA, a U.S. Agent
is responsible for the following activities:
- Keep a physical office in the USA
- Provide updates of the establishment registration and product
listing
- Be responsible to provide communications between the FDA and the
Company, ie. upcoming inspections of the foreign site
In addition to the responsibilities of the U.S. Agent, the foreign
facility has the following responsibilities:
- Provide mdi an update of changes to the Establishment registration
(e.g. address, change in ownership)
- Notify mdi of any new products or changes to already listed
products (e.g. dropping them from the product line)
- Notify mdi of changes in telephone numbers, fax numbers or email
addresses.
WHAT IS mdi’s U.S. AGENT PROGRAM?
In addition to the required responsibilities of a U.S. Agent
described above, mdi provides its clients the following additional
services:
- Updated newsletters or information on US regulations that might
effect the foreign manufacturer
- Discounted rates on other mdi services (e.g. FDA audits, GMP
training HACCP)
WHAT IS THE COST OF mdi’s U.S. AGENT PROGRAM?
The price of the service is $600/year. If you pay in advance for 3
years of service, the fee is $1,500.
HOW DO YOU SIGN UP FOR mdi’s U.S. AGENT PROGRAM?
Please go to our sign up page to sign up for mdi’s U.S. Agent
Program. Click here for the
Sign-up Page.
If you have specific questions you can call us at +1 (516) 482-9001
(ask for Diane Furnari or Alan Schwartz) or e-mail us at info@mdiconsultants.com
