February 11, 2002:
The 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".

December 12, 2003:
All foreign food facilities must include the name of a "US Agent" with their registration with FDA.

Wellkang LLC is your reliable "US Agent" registered with FDA for both Medical Devices & Foods. Click to learn more

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

During FY2007 (Oct. 1, 2006 - Sept. 30, 2007), FDA standard review fee for 510(k) submission is US$4,158. Fee for small business (annual sales less than US$100 million) is 80%, i.e. US$3,326

www.510k.us   www.510k.org

   US FDA 510(k) Overview
          Section 510(k) of the US Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Click here to learn more ...

In Chinese  CE Marking (CE Mark)- Your Trade Passport to Europe!
           CE Marking is a mandatory mark for many of the products circulated on the EFTA & European Union (EU) single market (totally 28 countries) and it is often referred as the "Trade Passport to Europe" for non-EU products. Click here to learn more ...

   CCC Mark- China Compulsory Certification mark
           Fully effective on August 1 2003, CCC Mark is required for a wide range of manufactured products, covered by a catalogue (in 19 groups divided into totally 132 product categories) should acquire the CCC mark before it can be marketed, imported or used for any commercial purposes in China. Click here to learn more ...

  Wellkang Online Shop
          You can order online by credit cards more than 150 updated CE Marking and CCC mark related publications: EU Directives, Regulations, Guidelines, Frameworks, Mutual Recognition Agreements, Lists of Testing Labs, European & Chinese Standards. Click here to Order Now!
Want to increase your export to Europe? Let top European import/export consultants help you! click on this banner to learn more ->>
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