mdi ConsultantsIt Is That Time of the Year Again…
FDA Annual Establishment Renewal and Drug Listing Certification
The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of Product Listing if you are acting as an authorized agent for the registered establishment.
(Please note: mdi has been providing this service for many of our clients. For Domestic companies their Off. Corresp. and foreign companies their US Agent and Official Correspondent.)
Basic Information About U.S. Agents
WHAT IS THE DEFINITION OF A FOREIGN FACILITY?
The final rule states that all foreign establishments of medical devices, human and animal drugs, and biologicals who manufacturer any of these products must have a designated agent in the USA:
- Medical device manufacturers
- Human drug manufacturers
- Animal drug manufacturers
- Biological manufacturers
WHAT WILL YOUR U.S. AGENT DO?
Based on the responsibilities outlined by the U.S. FDA, a U.S. Agent is responsible for the following activities
- U.S. Agent Program for Pharmaceutical / Medical Device Manufacturers
- 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 their Agent an update of changes to the Establishment registration (e.g. address, change in ownership)
- Notify their Agent of any new products or changes to already listed products (e.g. dropping them from the product line)
- Notify their Agent of changes in telephone numbers, fax numbers or email addresses.