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FDA News 1 - US Agent |
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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.
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FDA News 2 - Payment |
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April 1, 2003:
FDA stops accepting 510(k) submissions unless the FDA review fees are fullly paid in advance.
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FDA News 3 - Fees |
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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.
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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!
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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.
Click here to Order Now!
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