US FDA requires establishments that are involved in the production and distribution of
1)Prescription Drugs,
2)OTC Drugs,
3)API Manufacturers,
4)Sterilization service provider,
5)Medical devices manufacturer which are intended for commercial distribution in United States are required to register their facility with FDA. The registration needs to be done annually every year.
Do Foreign Establishements also need to Register with FDA?
Yes 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.
What is the difference between 510k Application and Establishment Registeration?
A 510K application is for Pre market approval for a medical device. while establishment registeration is for site.
How to Register your product with US FDA?
Step 1-Contact Perfect Pharmaceutical Consultants Pvt Ltd - we will help you register your site
Step 2-Classification of your Medical device as per USFDA CLassiifcation
Step 3-Registeration and Listing of Medical Device or 510K Application for pre approval as per the classification of Medical Device.
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.
