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Guidelines on Usage of FDA References

 

Dear Alibaba.com members,

 

To further standardize the proper use and referencing of product certificates, the Certificate Center will prohibit the uploading of FDA related certificates on Alibaba.com and remove any linkage between products and FDA certificates, effective from July 14, 2020.

 

Any references to FDA certificate or FDA approval (including but not limited to uploading of self-acclaimed FDA certificates or phrases referring to "FDA Approved", "FDA Cleared", "FDA Certified", "FDA Endorsed", and/or "FDA Listed Product") shall not be displayed on Alibaba.com.

 

Please refer to the following FAQ for further details.

 

Yours Sincerely,

Alibaba.com

 

FAQs on Usage of FDA References:

 

  1. Our company has completed registration with FDA. How can we obtain a registration certificate that is recognized by FDA?
  2. has confirmed that it does not issue any certificates to certify or verify any business enterprise’s registration with the FDA (for detailed information, please visit https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing). Merchants do not need to engage any third party (including but not limited to any registration intermediary, export or foreign trade chamber, or certification service provider) to issue registration certificates as such certificates would not be recognized by FDA, nor would such certificates be allowed to be displayed on Alibaba.com.

 

  1. Why are merchants forbidden to display the available FDA registration certificate?

FDA would not authorize any third parties (including but not limited to any registration intermediary, export or foreign trade chamber, or certification service provider) to issue any certificate on its behalf. Such certificates would not be recognized by FDA and shall not be displayed on Alibaba.com by any merchant.

 

  1. Our company has completed registration with FDA. Does that mean our company and/or products have been certified by FDA? Why are we disallowed to claim our company and/or products to be "FDA Approved" or "FDA Certified" even if we have completed registration?

Annual registration with FDA is a mandatory compliance requirement for all business enterprises and sellers who plan to manufacture and sell their products to the US. The completion of registration does not denote FDA's certification or recognition of a merchant or its products. To obtain a FDA approval for a product, a merchant’s products would need to meet FDA standards and apply for a Premarket Notification Approval or a 510(k) Clearance Letter.

 

  1. Can I display any information about the completion of registration with FDA on my storefront?

Merchants that have completed registration with FDA can display the following statement on the merchant capability page: "Status: FDA Registered Company". Any such statement shall be a statement of fact and not a representation that the company and/or their products have been certified or approved by FDA. As for the sale of personal protective equipment, only sellers who have been confirmed by the China Chamber of Commerce for Import & Export of Medicines & Health Products to have completed registration with FDA can display the above statement. To inquire about the FDA-related qualifications of sellers, please visit: http://www.cccmhpie.org.cn/kywz.aspx.

 

  1. Why has the FDA logo displayed next to my products been removed?
  2. has strict guidelines on the use of its logo (for detailed information, please visit: https://www.fda.gov/about-fda/website-policies/fda-logo-policy). It is stipulated in its guidelines that the FDA logo cannot be arbitrarily used by the private sector. This prohibition does not apply only to personal protective equipment but to all products in general on Aibaba.com unless specifically authorized by FDA.

 

  1. If we have obtained a Premarket Approval (PMA) number or a 510(k) premarket submission number for our products, can we display the information on Alibaba.com?

Merchants who have obtained a PMA number or a 510(k) premarket submission number can display the number only on the product detail page.

 

  1. How can we inquire whether we have obtained a PMA number or a 510(k) premarket submission number for our products?

You can refer to FDA's database (for PMA numbers, please visit:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm; for 510(k) premarket submission numbers, please visit: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) to inquire about the validity or status of your PMA number or 510(k) premarket submission number.

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