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Assessment Sheet IVD

FDA medical device registration sheet form for assessment per requirements for the registration of medical devices

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-03 Annex 02
Rev. No. 01 Date Effective: 18 October 2017

ASSESSMENT SHEET AS PER CHECKLIST OF REQUIREMENTS FOR THE
REGISTRATION OF AN IN VITRO DIAGNOSTIC DEVICE
Name of Product : _____________________________________________________________________________
Company Name & Address: _____________________________________________________________________
Evaluator
: _____________________________________________________________________________
Date Evaluated : _____________________________________________________________________________

REQUIREMENTS
1. Table of Contents (with page number)
2. Notarized Application Form from Distributor
(Importer/Exporter/Wholesaler) /Local Manufacturer/Trader
3. Certificate of Brand Name Clearance (for branded products, if
applicable)
4. Valid License to Operate (LTO) of an IVD Distributor
(Importer/Exporter/Wholesaler)/Local Manufacturer/Trader
5. Valid Government Certificate of Clearance and Free Sale/Registration
approval of the Product from the country of origin issued by the Health
Authority and duly authenticated by the territorial Philippine Consulate
for Imported Product
6. Valid Government Certificate attesting to the status of the
manufacturer, competency and reliability of the personnel and facilities
or valid ISO Certification and duly authenticated by the territorial
Philippine Consulate
7. Copy of latest Certificate of Product Registration, if applicable
8. Certificate of Foreign Agency Agreement between the manufacturer
and trader/distributor/importer regarding the product involved duly
authenticated by the territorial Philippine Consulate
9. Intended use and Directions for Use
10. List of all raw materials used as components of the reagents/test kit
11. Technical specifications and physical description of the Finished
Product
12. Process-control/Test Procedure and expected performance
specification
13. Brief description of the methods used in the facility and the controls in
the manufacture, processing, packaging of the IVD and the process
flowchart showing an overview of production
14. Risk analysis with control measures
15. A. For INITIAL: Stability test data and results describing the shelf life,
in-use stability, and the shipping stability studies to justify claimed
shelf life. The testing should be performed on at least three (3)
different product lots manufactured under conditions that are
essentially equivalent to routine production conditions.
B. For RENEWAL: Stability test data and results describing the shelf
life. The testing should be performed on at least three (3) different
product lots manufactured under REAL TIME CONDITION.
16. A. For INITIAL: Labeling materials to be used for the product:
Immediate label, secondary packaging, box label and package
insert/brochure.
B. For renewal, submit clear and readable commercial product label
specimen of all labeling materials (outer, immediate, package insert)
17. For pregnancy test kit, 15 samples of the same lot with at least nine
(9) months expiration date. For other IVD applications, samples will
be submitted directly to the respective NRLs. No. of samples required
will depend on the requirement of each NRL.
18. Evidence of registration fee/payment (charge slip/official receipt)

YES

NO

REMARKS
 
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