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Checklist Requirements COE

FDA medical device registration checklist for the requirements of certificate of exemption for product registration

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-05 Annex 02
Rev. No. 05 Date Effective: 18 October 2017

CHECKLIST OF REQUIREMENTS FOR CERTIFICATE OF
EXEMPTION FOR PRODUCT REGISTRATION
1.
2.
3.
4.

Letter of Intent regarding exemption of the device/product from registration
Photocopy of Product Brochure (s)
License to Operate as Medical Device Distributor/Importer/Exporter
Fee (computation of fee is per product as indicated in the letter of intent)
 
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