Wellkang® LLC
February 11, 2002:
   FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.

   Wellkang LLC is your reliable “US Agent” in dealing with FDA.

April 1, 2003:
   FDA stops accepting 510(k) submissions unless the FDA review fees are fullly paid in advance.

October 01, 2004:
   During FY2005 (Oct. 1, 2004 - Sept. 30, 2005), FDA standard review fee for 510(k) submission is US$3,502. Fee for small business (annual revenue under $30 Million) is 80% of standard fee, i.e. US$2,802.

  FDA Service Shopping

Wellkang can act as the "US Agent", of non-US manufacturers of medical devices, food & food products, cosmetics, etc, as required by US FDA regulations.

Wellkang also provide FDA Compliance Consulting services such as: Food Labeling, 510K PMN Submission, Product Listing/Registration, Resolution of FDA 483 & warning letters, import and export problem solving, etc...

Click here to order our service Now!

  Wellkang can deliver, normally within 48 hours, via email/download CE Marking and CCC Mark publications (all in .PDF version). You can play an order online by using major bank cards.

One-Stop CCC Mark Shopping-
Here are ALL you need to know about CCC Mark-China Compulsory Certification mark (>50 publications): Regulations, Guidelines, Lists of Authorized Testing Labs & Certification Bodies, Chinese Standards.

One-Stop CE Marking Shopping-
Here are ALL you need to know about CE Marking (>100 publications): European Product Directives, Guidelines to Applications of Directives, Framework of Implementation of Directives, Mutual Recognition Agreements between EU & other countries, complete lists of all (1000+) Notified Bodies, complete lists of European and/or international standards related to CE Marking, as well as other publications.

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