Medical Devices

 U.S.FDA Consultants India - Establishment Registration

Establishment Registration US FDA Consultants India

US FDA requires establishments that are involved in the production and distribution of medical devices which are intended for commercial distribution in United States are required to register their facility with FDA. The registration needs to be done annually.

Even Foreign establishment’s needs to register with USFDA, additionally most of the establishment required to registered with US FDA need to list their device and the activities performed on those devices at the registered establishment.

510 K application is different from establishment registration. A 510K application is for Pre market approval for a medical device.

There is an Annual User fee for establishment registration which needs to paid to US FDA.

Perfect Pharmaceutical Consultants Can assists you with
  • Identifying if your firm needs to be registered with US FDA???
  • Classification of your Medical Device??
  • Registration Procedure – Road Map to get your product to US FDA.
Request for Identification information & Classification information – “”Without Any Obligation now””