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Checklist Requirements Renewal CPR

FDA medical device registration checklist for the requirements for the renewal of certificate of product registration of a medical device

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-02 Annex 03
Rev. No. 05 Date Effective: 18 October 2017

CHECKLIST OF REQUIREMENTS FOR RENEWAL OF CERTIFICATE OF
PRODUCT REGISTRATION OF A MEDICAL DEVICE
1.
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6.
7.

Table of Contents (with page number)
Notarized Application Form
Copy of Valid License to Operate
Copy of Certificate of Product Registration
Copy of valid Authenticated Foreign Agency Agreement
Copy of Valid Authenticated GMP/ISO Certification
Clear and readable commercial product label specimen of all labeling materials per pack size/code
(outer, immediate, package insert, if applicable)
8. Clear and colored photo of the actual commercial product sample without its packaging
9. Payment Assessment Slip
10. Fee

NOTE:
•
Submit clear and readable electronic/scanned copy (in PDF Searchable Format of at least
150dpi)
 
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