Are you a non-US manufacturer of Pharmaceutical Products & Medical Devices, or Foods & Food Products? Let Wellkang LLC be your reliable US Agent registered with the FDA - U.S. Food and Drug Administration!

Our Services & Fees for Medical Devices & Pharmaceutical Products:

Since February 11, 2002, ALL Foreign Establishments whose products (Human Drugs, Animal Drugs, Biological Products, and Devices) are imported or offered for import into the United States MUST be REGISTERED with the FDA and designated a United States Agent, i.e. a “US 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 ESTABLISHMENT?

The Foreign Establishment means any of the follows:
1. Medical device manufacturers
   
2. Human drug manufacturers
   
3. Animal drug manufacturers
   
4. Biological manufacturers
   

Wellkang Offer Excellent Services At Very Competitive Prices!

Services For Foreign Establishments of Pharmaceutical Products & Medical Devices:	Prices (in US$)
Medical Device Registration & Listing with FDA
Serve as U.S. Agent for Establishment Registration purpose	Fee varies, please click here to contact us for quotation.
Medical Device Classification Service	125.00 per product
Medical Device Listing with FDA	Fee varies, please click here to contact us for quotation.
Premarket Notification 510(k) Submission	Fee varies, please click here to contact us for quotation.
Premarket Approval (PMA) Application	Fee varies, please click here to contact us for quotation.
Drug Registration & Listing with FDA
Serve as U.S. Agent and provide Establishment Registration assistance	starting from 888.00 per year per establishment
Drug Product Listing with FDA	Fee varies, please click here to contact us for quotation.

US Congress authorized FDA to collect an annual establishment registration fee for device establishment registrations submitted to the FDA after September 30th, 2007, please learn more here.

Our Services & Fees for Foods & Food Products:

Since December 12, 2003, ALL food facilities (both domestic and foreign) MUST be registered with the FDA. Any foreign facilities not registered will have their goods held at the U.S. port of entry or moved to an FDA secure location. All foreign food facilities must include the name of a “US Agent” with their registration. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.

Food Facility Registration
Services For Foreign Food Facilities	1st Food Facility	2nd To 5th Food Facilities With Same Owner	6th And Additional Food Facilities With Same Owner
Serve as U.S. Agent and provide registration assistance	$499.00 per year per facility	$380.00 per year per facility	$289.00 per year per facility
Amendment to registration information	$95.00 per amendment per facility
Cancellation of registration	$95.00 per facility
Confirmation of registration to third party	$95.00 per confirmation per facility
Submit Prior Notice to FDA for Food Importation	$125.00 per Notice
Rush Service	add 50% per item
Food & Nutrition Labeling Services
Nutrition Facts Labels		$145.00 per label
Ingredient Statements		$125.00 per product
Final Food Label Reviews		$245.00 per label
Full Label Compliance Packages (combines the above 3 items)		$399.00 per product
Regulatory Question Research		$145.00 per question
Rush Service		add 50% per item
Additional Services
FCE (Food Canning Establishment) Submission		$95.00 per submission
SID (Submission Identifier) Submission		$175.00 per submission
Low-Acid Aseptic Submission		$125.00 per submission
Rush Service		add 50% per item